[{"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 15464BR\nJob Posting Title Sr Associate QA\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Job Description\n\nPosition Title: QA Snr Associate\nReports to:  QP\nGroup/Division: Amgen Dun Laoghaire\nDepartment:  QA\nShift        Yes 24/5\n\nPosition Summary:\n\nThis job specification outlines the general responsibilities associated with the role of QA Snr Associate at ADL. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.\n\nThe QA Snr Associates duties are as follows;\n\n\u2022 Compiles QC and Manufacturing batch records and reviews for compliance to cGMPs and\nProduct Licenses.\n\n\u2022 Review and approve Master Batch Records\n\n\u2022 Review non conformances for completeness\n\n\u2022 Prepare the agenda for Site Quality Review Team and submits non conformances for\nreview/discussion.\n\n\u2022 Prepares the SQRT minutes.\n\n\u2022 Assigns expiry date to products.\n\n\u2022 Prepare deviation trend reports bi annually to establish any evident trends.\n\n\u2022 Schedules products to be placed on the stability program\n\n\u2022 Status changes and yields product on the computer system\n\n\u2022 Prepares non conformance reports for shipments as required\n\n\u2022 Tracks CAPA\u2019s detailed in non conformance reports\n\n\u2022 Writes, reviews and approves Standard Operating Procedures in accordance with Amgen\nPolicies\n\n\u2022 Prepares Monthly Metrics.\n\n\u2022 Ensure compliance with Amgen procedures\n\n\u2022 Performs Quality Audits to ensure compliance with cGMPs\n\n\u2022 Maintains databases and other informational systems as necessary.\n\n\u2022 Prepares the KPI reports as required.\n\n\u2022 Complies with responsibilities as outlined in the site Safety Statement section 3.6.\n\n\u2022 Performs all tasks with due care and attention and in accordance with Good\nManufacturing Practices and Amgen requirements, policies and procedures.\n\n\u2022 Participates in a learning and development programme which will include goal setting, annual performance reviews and   individual development plans.\n\n\u2022 Is a champion for safe working practices and safety initiatives within their functional\narea.\nBasic Qualifications Education:\n\nThird level qualification, preferably to degree level, in a Science discipline.\n\nExperience:\n\nMinimum three years industrial experience or equivalent\nPreferred Qualifications Knowledge and training in QMTS, SAP, EBR and Maximo  Strong organizational skills and ability to manage multiple tasks at one time Ability to follow assignments through to completion and meet timelines Self motivated Strong communication skills (both written and verbal) Demonstrated ability to work as both a team player and independently Ability to evaluate documentation and operations according to company procedures Ability to make decisions independently or elevate to management, as appropriate in an environment that balances business need, quality and compliance risk Strong word processing, database and spreadsheet application skills", "date_new": "2012-05-17 20:58:26", "url": "http://www.amgen.jobs/xml/28771078/job", "country": "Ireland", "company": "Amgen", "title": "Sr Associate QA", "reqid": "15464BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 28771078}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 15363BR\nJob Posting Title Mgr Maintenance\nCareer Category Maintenance\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Maintenance Manager \u2013 Level 5\nAmgen Dun Laoghaire - Dublin\n\nThis role leads a small group of engineers / technical professionals delivering a technical service requiring the job holder to apply knowledge and experience of engineering principles to a broad variety of assignments. Principally the jobholder will develop technical solutions to complex problems, while managing, coordinating and reviewing the work of others.\n\n\u2022Carry out fault investigation and problem analysis for maintenance related issues, identify alternative solutions, prepare proposals for modifications or improvements and execute/trial as necessary\n\n\u2022Provide input at various project stages to review maintainability \u2013 be involved in new equipment installation and accept handover from project teams to maintenance. Check technical content of handover documentation and ensure PM system is updated.\n\n\u2022Administer control and develop PM System, provide technical input for developing PM\u2019s and for other maintenance aspects of maintenance documentation; assisting with equipment/process fault identification and improvements.\n\n\u2022Administer and control planned maintenance systems ensuring work orders are issued, completed and returned on time, running reports, analysing trends and issuing proactive worksheets.\n\n\u2022Provide technical input into preparation and issue of SOP\u2019s; corrective action tracking; operation and maintenance manuals.\n\n\u2022Assist with preparation and co-ordination of shutdown activities, manage and review activity schedules and produce summary reports\n\n\u2022Conduct area self assessment and implement corrective actions, evaluate new equipment/processes for safety issues related to maintenance functions. Conduct departmental risk assessment in conjunction with the EHS department.\n\n\u2022Participation in \u2018call-out system\u2019 to cover Engineering response (out of normal hours, management of weekend maintenance activities\nBasic Qualifications \u2022Bachelor's degree in Engineering, Science or related field.\n\n\u2022Significant relevant work experience within operations/manufacturing environment\n\n\u2022Direct experience with regulated environments (i.e. cGMP, OSHA, EPA)\n\n\u2022Established expertise in multiple areas of engineering technology.\nPreferred Qualifications \u2022Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.\n\n\u2022Working knowledge of financial analysis tools' and appreciation for project cost development\n\n\u2022Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation.\n\n\u2022Written communication including technical writing.\n\n\u2022Team leadership skills: Management, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.", "date_new": "2012-04-27 20:21:28", "url": "http://www.amgen.jobs/xml/28241185/job", "country": "Ireland", "company": "Amgen", "title": "Mgr Maintenance", "reqid": "15363BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 28241185}, {"country_short": "IRL", "city": "Field Based", "description": "Auto req 14626BR\nJob Posting Title Regional Medical Liaison\nCareer Category Sales\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Field Based\nAmgen Job Description This position is a Regional Medical Liaison (RML) field-based position for the Bone Therapeutic Area in Ireland covering Maternity Leave for a 9-month period.\n\nThe RML will interact with key opinion leaders/healthcare professionals to communicate and advance the scientific platform, as aligned with Amgen's corporate goals, objectives and affiliate medical plans and provide feedback based on those field interactions. The RML will foster relationships with key healthcare professionals including key registrars and nurses. The RML is an integral position in assuring accuracy in communication of our science and products across the medical community.\n\nThe RML will communicate complex cutting edge, scientific information and research concepts to healthcare professionals and support Amgen sponsored research.\n\nThe RML will represent Amgen medical department in the fiels within the Bone Therapeuticc Area in compliance with local and Amgen regulatory standards.\nBasic Qualifications Medical or scientific education with a minimum 3 years experience in similar positions or related jobs such as Medical Communications, Nurse Advisor, CRA or Medical Liaison.\nPreferred Qualifications Advanced degree (e.g. PhD, MD) preferred or strong demonstration of equivalent combination of relevant educational and professional training.\n\nExperience:\n- Working in the bone field\n- Setting up and running research studies in a hosspital environment\n- Knowledge of regulatory affairs, drug safety, legal and compliance environment (IPHA OR ABPI)\n- Network of customer contacts in bone field\n- PhD in a bioscience discipline", "date_new": "2012-04-13 02:24:03", "url": "http://www.amgen.jobs/xml/27868810/job", "country": "Ireland", "company": "Amgen", "title": "Regional Medical Liaison", "reqid": "14626BR", "state": null, "state_short": null, "location": "Field Based, IRL", "uid": 27868810}, {"country_short": "IRL", "city": "Cork", "description": "Auto req 14214BR\nJob Posting Title Engineering Projects Mgr\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Cork\nDublin\nField Based\nDun Laoghaire\nAmgen Job Description Engineer Project Manager - Packaging\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the packaging group and be responsible for the execution of all projects in that area. The equipment engineer reports to the Sr. Manager Manufacturing \u2013Packaging. The candidate will apply technical expertise in the management of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes.\n\nResponsibilities include:\n\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Engineering Project lead for Packaging\n\u2022 The provision of manufacturing input to all capital projects relating to the area.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 All design reviews associated with equipment purchases.\n\u2022 The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.\n\u2022 Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.\n\u2022 Continuous improvement programs\n\u2022 Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-04-04 03:03:14", "url": "http://www.amgen.jobs/xml/27630466/job", "country": "Ireland", "company": "Amgen", "title": "Engineering Projects Mgr", "reqid": "14214BR", "state": null, "state_short": null, "location": "Cork, IRL", "uid": 27630466}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13504BR\nJob Posting Title Sr Mgr Manufacturing - Vial Fill\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Manager Manufacturing - Vial Fill\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will report to the Director of Manufacturing. The ideal candidate will provide strong management and leadership in the Manufacturing \u2013 vial fill facility.\n\nKey Responsibilities:\n\n\u2022 Manage the Vial Fill Manufacturing Facility department.\n\u2022 Lead in the development of long range planning (LRP) to maintain the highest level of productivity.\n\u2022 Lead in the development of Manufacturing\u2019s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals.\n\u2022 Develop, maintain, and justify the departments\u2019 budgets.\n\u2022 Responsible for ensuring that all manufacturing is carried out under GMP conditions and in a safe working environment.\n\u2022 Support the plant in the project approval, prioritization, and implementation process.\n\u2022 Develop metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based on the benchmarking data.\n\u2022 Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the manufacturing department.\n\u2022 Assure the appropriate level of training is undertaken for all levels of the manufacturing syringe organization which may involve developing training material.\n\u2022 Responsible for attaining and improving site based metrics targets.\n\u2022 Responsible for recruiting talented staff into the facility and setting standards for their performance.\n\u2022 This position will need to complete some travel to the other Amgen sites over the next two years.\n\n* Other functions may be assigned.\nBasic Qualifications Basic Qualifications\n\n\u2022 Typically 8+ years of experience in facilities management position. With typically 4+ years experience supervising technical staff\n\u2022 Bachelor\u2019s Degree or combination of education and/or years of experience.\nPreferred Qualifications Preferred Qualifications\n\n\u2022 Knowledge of conflict resolution\n\u2022 Ability to partner with other departments.\n\u2022 Analytical problem solving.\n\u2022 Considerable Organization skills.\n\u2022 Experience in coaching, mentoring and counselling.\n\u2022 Ability to deal with and manage change.\n\u2022 Ability to set goals.\n\u2022 Knowledge of applicable regulatory guidelines\n\u2022 Ability to use company compensation system including mentoring lower management levels when required.\n\u2022 Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.", "date_new": "2012-03-28 21:28:53", "url": "http://www.amgen.jobs/xml/27464075/job", "country": "Ireland", "company": "Amgen", "title": "Sr Mgr Manufacturing - Vial Fill", "reqid": "13504BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 27464075}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14509BR\nJob Posting Title Engineer - Packaging\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Packaging Engineer\n\nAmgen Job Description Packaging Engineer - Process Development\n\nThis position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components, the associated systems such as documentation, equipment and processes.\n\nKnowledge of primary and secondary packaging systems and processes, packaging equipment, components and packaging processes, material science and quality system is essential to the position.\nThe position will leverage organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\n\nThis position is responsible and accountable for the following:\n\n1) Evaluation, recommendation and selection of primary and secondary packaging materials, equipment , and vendors\n2) Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials / equipment.\n3) Write Technical Specifications, SOP\u2019s and Bill of Materials\n4) Representing Process Development in Drug Product and Global Operation Teams as required\n5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n6) Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n7) Ensures cGMP and regulatory compliance are met at all times\n8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n9) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n10) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems in a timely manner.\n11) Excellent problem solving and RCA skills. Excellent report writing skills.\n12) Support the NPI process\n13) Effectively review and close out non conformances by CAPA\n14) Participate in FAT, SAT\n\nDemonstrated Competencies/Skills:\n1) Independent thinker with demonstrated skills working in teams or leading project teams\n2) Strong Interpersonal and communication skills\n3) Ability to multi-task and manage tight timelines\n4) Excellent report writing skills\n5) Proven problem solving skills and indepth knowledge of problem solving methodologies\n6) Knowledge of Regulatory environment\n7) Flexible and adaptive \u2013 this position will involve travel and shift work.\nBasic Qualifications Basic Qualifications \u2022 Degree / diploma in engineering discipline with 5 + years relevant pharmaceutical packaging experience\nOr\n\u2022 Degree / diploma in packaging technology / materials sciences with 5 + years relevant pharmaceutical packaging experience", "date_new": "2012-03-22 18:49:02", "url": "http://www.amgen.jobs/xml/27320620/job", "country": "Ireland", "company": "Amgen", "title": "Engineer - Packaging", "reqid": "14509BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 27320620}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14194BR\nJob Posting Title Training and Development Manager\nCareer Category Training\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description The Training and Development Manager will be responsible for developing partnerships with key clients while influencing and establishing operating standards and practices.\n\nTo be successful in this role you will need to complete the following:\n\n\u2022 Under minimal supervision, partners with the client to apply human performance theory and needs\nanalysis skills to analyze performance issues and identify solutions that support business\nneeds.\n\u2022 When a training need is identified, can utilize instructional design and adult learning\nmethodologies to design and develop solutions in a variety of delivery formats.\n\u2022 Manages assigned projects.\n\u2022 Works with internal clients to manage their curricula and assignments and ensure all training\nmaterials are integrated with Amgen\u2019s learning management system per defined business processes.\n\u2022 Supports the gathering and evaluation of metrics that ensure the effectiveness of performance\nsolutions and training materials.\n\u2022 Serves as an internal client\u2019s first point of contact for performance and training questions.\n\u2022 Leads global training forum for client function and represents client during Operations global\ngovernance and prioritization processes.\n\u2022 Writes instructional materials, leader\u2019s guides, etc, and able to modify existing material.\n\u2022 Develops and conducts Train-the-Trainer classes/support as needed.\n\u2022 Works with audit response teams to ensure appropriate actions are taken.\n\u2022 Provides proactive strategic planning to client regarding future performance needs and global\ncurricula projects.\n\u2022 Serves on sustainment steering committee for applicable global programs.\n\u2022 Ensures that training content is current and reflects all technical and compliance standards.\nBasic Qualifications \u2022 Bachelors Degree or comparable professional experience in Instructional Design, Human\nPerformance Technology, Life Sciences, or Business\n\u2022 5+ years experience as a performance consultant, instructional designer, and/or curriculum\ndeveloper\n\u2022 Knowledge of adult learning theory, instructional design, performance consulting, and needs\nanalysis\n\u2022 Experience using ADDIE or other instructional design methodology in the creation of training\nmaterials\n\u2022 Experience supporting and/or creating materials for on-the-job training\n\u2022 2+ year project management (managing projects, defining scope, overseeing budget, tracking\nmilestones)\n\u2022 Travel, up to 10%\nPreferred Qualifications \u2022 2 years experience in Microsoft Word, PowerPoint, and Excel\n\u2022 Any experience with business processes surrounding the use of learning management or training\nsystems (i.e., SumTotal, ISOtrain)\n\u2022 Experience working in a regulated environment (FDA, OSHA, NRC, etc.)\n\u2022 1 year experience with Visio and MS Project\n\u2022 eLearning design experience and knowledge of online performance support tools\n\u2022 Ability to work with staff across all levels of an organization\n\u2022 Effective communication and writing skills", "date_new": "2012-03-21 18:36:06", "url": "http://www.amgen.jobs/xml/27297538/job", "country": "Ireland", "company": "Amgen", "title": "Training and Development Manager", "reqid": "14194BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 27297538}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14198BR\nJob Posting Title Sr Associate Training & Development\nCareer Category Training\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Under limited supervision, delivers training programs to support business needs. Performs on-the-job training demonstrations and coaching sessions in a learning lab or actual production environment. Conducts classroom training. Works closely with assigned client groups to assess and meet training needs.\n\n\nFUNCTIONS\n\n\u2022 Responsible for effective delivery of training to client group. Includes classroom, one-on-one,\nand on-the-job training. Could also ensure effective delivery of eLearning courses.\n\u2022 Works closely with assigned clients, in their work environment, to understand and assess\nspecific training needs.\n\u2022 Communicates client training needs to local training management.\n\u2022 Responsible for delivery of solutions to meet the specific training needs of assigned clients.\n\u2022 Responsible for effective delivery of cGMP and other regulatory training, as required by client\ngroup.\n\u2022 Delivers initial and ongoing training for new hires and transfers. Facilitates transition of new\nhires/transfer-ins from training environment to work environment.\n\u2022 Facilitates the assignment and un-assignment of training courses/modules for staff members.\n\u2022 Provides guidance to client on compliance and regulatory issues.\n\u2022 Participates and /or leads inspections activities.\n\u2022 Coaches and develops SME/ certified trainers within client area to be effective trainers.\n\u2022 Assists in review of human error\u201d-related incidents: determine need for additional or modified\ntraining interventions for affected staff.\n\u2022 May provide input into the implementation of corporate core curricula and standard learning\nprocesses.\n\u2022 May participate on global training teams as assigned.\n\u2022 May include small scale training design projects to meet local client needs.\nBasic Qualifications Master\u2019s degree OR Bachelor\u2019s degree & 2 years of of experience directly related to the job OR Associate\u2019s degree & 6 years of experience directly related to the job.\nPreferred Qualifications \u2022 Strong customer service orientation and influencing skills to work directly with client staff\nand identifying performance needs.\n\u2022 Working knowledge on computer software programs including: Word, Excel, and Power Point.\n\u2022 Works directly with client in delivering training.\n\u2022 Demonstrates understanding of Amgen\u2019s business and culture, and ability to work effectively with\nstaff at all levels\n\u2022 Technical competency commensurate with assigned area(s) of responsibility\n\u2022 Regulatory compliance competency commensurate with assigned area(s) of responsibility Skilled in\nprocess modeling and troubleshooting\n\u2022 Basic project management skills\n\u2022 Good interpersonal, group facilitation and presentation skills\n\u2022 Able to accomplish results through own work and through influencing client staff members and\nmanagement", "date_new": "2012-03-21 18:35:48", "url": "http://www.amgen.jobs/xml/27297532/job", "country": "Ireland", "company": "Amgen", "title": "Sr Associate Training & Development", "reqid": "14198BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 27297532}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14039BR\nJob Posting Title 2 x Manager Manufacturing - Syringe Filling & Inspection\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Manager Manufacturing \u2013Syringe Filing & Inspection\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Manager Manufacturing \u2013 Syringe Filling & inspection reports to the Sr Manager Manufacturing \u2013 Syringe and will be responsible for the manufacturing teams within the syringe filling facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.\n\nResponsibilities include:\n\n\u2022 Responsible for filling and inspection line output during their shift.\n\u2022 Responsible for ensuring that all staff operate within GMP\u2019s and maintaining a safe work environment.\n\u2022 Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.\n\u2022 Responsible for ensuring that all staff operate within GMP\u2019s and maintaining a safe work environment.\n\u2022 Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.\n\u2022 Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.\n\u2022 Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.\n\u2022 Prepared to work on a shift basis, leading a manufacturing team.\n\u2022 Able to travel to other sites within the organization for certain time periods.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering or Science\n\n\nRelevant Experience\n\u2022 Typically 5 \u2013 8 years experience in an aseptic pharmaceutical environment.", "date_new": "2012-03-07 02:05:41", "url": "http://www.amgen.jobs/xml/26971935/job", "country": "Ireland", "company": "Amgen", "title": "2 x Manager Manufacturing - Syringe Filling & Inspection", "reqid": "14039BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971935}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14042BR\nJob Posting Title Sr Engineer - Packaging (Line Owner)\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Engineer \u2013 Packaging\n(Line Owner)\nLevel 5\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the packaging group and be responsible for the execution of all projects in that area. The Sr. Engineer reports to the Sr. Manager Manufacturing \u2013Packaging. The candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to packaging equipment and associated automation systems.\nResponsibilities include:\n\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Monitoring of day to day manufacturing operations.\n\u2022 Data trend analysis for all performance aspects of a packaging line.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 Solving or escalating problems as appropriate.\n\u2022 All design reviews associated with equipment purchases.\n\u2022 Troubleshooting performance trends.\n\u2022 Risk assessments and mitigation projects relating to line performance.\n\u2022 Support of new product introductions and supporting introduction of new equipment.\n\u2022 The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.\n\u2022 Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.\n\u2022 Continuous improvement programs and all performance improvement projects.\n\u2022 Review and approval of changes to operating procedures and the change control process relating to the line.\n\u2022 Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\n\u2022 Supporting non conformance investigation.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-03-07 02:05:14", "url": "http://www.amgen.jobs/xml/26971791/job", "country": "Ireland", "company": "Amgen", "title": "Sr Engineer - Packaging (Line Owner)", "reqid": "14042BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971791}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14037BR\nJob Posting Title 4 x Manager Manufacturing - Packaging\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Manager Manufacturing \u2013 Packaging\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Manager Manufacturing \u2013 Packing reports to the Sr Manager Manufacturing \u2013 Packaging and will be responsible for the manufacturing teams within the syringe packaging facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.\n\nResponsibilities include:\n\n\u2022 Responsible for filling and inspection packaging line output during their shift.\n\u2022 Responsible for ensuring that all staff operates within GMP\u2019s and maintaining a safe work environment.\n\u2022 Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.\n\u2022 Responsible for ensuring that all staff operates within GMP\u2019s and maintaining a safe work environment.\n\u2022 Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.\n\u2022 Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.\n\u2022 Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.\n\u2022 Prepared to work on a shift basis, leading a manufacturing team.\n\u2022 Able to travel to other sites within the organization for certain time periods.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering or Science\n\n\nRelevant Experience\n\u2022 Typically 5 \u2013 8 years experience in an aseptic pharmaceutical environment.\n\u2022 Previous experience working on packaging lines in a man management role is a distinct advantage.", "date_new": "2012-03-07 02:05:13", "url": "http://www.amgen.jobs/xml/26971785/job", "country": "Ireland", "company": "Amgen", "title": "4 x Manager Manufacturing - Packaging", "reqid": "14037BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971785}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14038BR\nJob Posting Title Senior Engineer - Industrial\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Engineer \u2013 Industrial\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the packaging and syringe groups and be responsible identifying and remediating gaps between emerging business requirements and current capabilities within the filling and packaging operations. The Sr. Engineer reports to the Sr. Manager Manufacturing \u2013 Syringe.\n\nResponsibilities include:\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Performing resource assessments for each area and developing resource standards and labour models\n\u2022 Data trend analysis for all performance aspects of the area.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 Solving or escalating problems as appropriate.\n\u2022 Leading improvement initiatives in areas of waste reduction, right first time approaches and productivity improvement.\n\u2022 Troubleshooting performance trends.\n\u2022 Risk assessments and mitigation projects relating to line performance.\n\u2022 Performing resource gap analysis for machinery and labour and developing strategies to close these gaps.\n\u2022 Continuous improvement programs and all performance improvement projects.\n\u2022 Working with the operational excellence group in implementing OE methods, mentoring project leads and facilitating process improvement teams.\n\u2022 Review and approval of changes to operating procedures and the change control process relating to the line.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Qualification in Lean and 6-sigma methodologies would be an advantage.\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-03-07 02:05:06", "url": "http://www.amgen.jobs/xml/26971749/job", "country": "Ireland", "company": "Amgen", "title": "Senior Engineer - Industrial", "reqid": "14038BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971749}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14211BR\nJob Posting Title 2 x Sr Associate Tech Engineering - Syringe\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Associate Tech Engineer - Syringe\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Sr. Associate Tech Engineer operates as part of a process team. This position will initially be part of the team responsible for the commissioning, qualification and start up of Amgen\u2019s new syringe manufacturing facility. On completion of the start up, this position will transition to providing technical support to the manufacturing facility.\n\nKey Responsibilities:\n\nDuring start up the individual will execute all project activities associated with start up of the syringe line, including but not limited to:\n\u2022 Participation in equipment design reviews.\n\u2022 Development and execution of FAT, SAT, IOQ protocols.\n\u2022 Development, revision and review of technical documents such as SOP\u2019s, job plans etc.\n\u2022 A willingness to spend time abroad over the next 2 years.\n\u2022 Ensuring that work is completed in a safe manner under GMP conditions and in accordance with applicable Amgen procedures.\n\nDuring routine manufacturing operations, the individual will provide technical support to the syringe line by:\n\u2022 Ensuring that daily output and compliance requirements are met.\n\u2022 Tracking equipment and process performance to ensure compliance with operating standards.\n\u2022 Implementing corrective actions when deviations from standard are detected.\n\u2022 Ensuring that maintenance personnel have clear definition/guidance when equipment problems are encountered and improvement is required.\n\u2022 Working to investigate, resolve and closeout all issues relating to NC\u2019s, CAPA\u2019s, process deviations.\n\u2022 Owning manufacturing area SOP\u2019s and change control reports.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Degree in Engineering/Science or equivalent\n\u2022 Significant relevant process engineering industry experience\n\nKey competencies:\n\n\u2022 Analytical thinking\n\u2022 Focus on quality\n\u2022 Drive for results\n\u2022 Initiative\n\u2022 Planning and prioritisation\n\u2022 Teamwork and Co-operation\nPreferred Qualifications Preferred Qualifications.\n\u2022 Excellent written and verbal communication skills\n\u2022 Knowledge of applicable Regulatory requirements\n\u2022 Experience with Regulatory inspections desirable\n\u2022 Experience leading cross-functional teams desirable\n\u2022 Experience working with teams and influencing decisions", "date_new": "2012-03-07 02:04:45", "url": "http://www.amgen.jobs/xml/26971668/job", "country": "Ireland", "company": "Amgen", "title": "2 x Sr Associate Tech Engineering - Syringe", "reqid": "14211BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971668}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14219BR\nJob Posting Title 2 x Manager Manufacturing \u2013 Syringe, Component Prep & Formulation\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Manager Manufacturing \u2013 Syringe, Component Prep & Formulation\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Manager Manufacturing \u2013 Syringe, Component Prep & Formulation reports to the Sr Manager Manufacturing \u2013 Syringe and will be responsible for the manufacturing teams within the syringe filling facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.\n\nResponsibilities include:\n\n\u2022 Responsible for filling and inspection line output during their shift.\n\u2022 Responsible for ensuring that all staff operate within GMP\u2019s and maintaining a safe work environment.\n\u2022 Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.\n\u2022 Responsible for ensuring that all staff operates within GMP\u2019s and maintaining a safe work environment.\n\u2022 Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.\n\u2022 Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.\n\u2022 Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.\n\u2022 Prepared to work on a shift basis, leading a manufacturing team.\n\u2022 Able to travel to other sites within the organization for certain time periods.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering or Science\n\nRelevant Experience\n\u2022 Typically 5 \u2013 8 years experience in an aseptic pharmaceutical environment.\n\u2022 Previous experience of management of Syringe filling and inspection operations is a distinct advantage.", "date_new": "2012-03-07 02:04:18", "url": "http://www.amgen.jobs/xml/26971519/job", "country": "Ireland", "company": "Amgen", "title": "2 x Manager Manufacturing \u2013 Syringe, Component Prep & Formulation", "reqid": "14219BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971519}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14217BR\nJob Posting Title Engineering Projects Manager - Syringe Fill\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Engineer Project Manager - Syringe Filling\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the syringe group and be responsible for the execution of all projects in that area. The equipment engineer reports to the Sr. Manager Manufacturing \u2013Syringe. The candidate will apply technical expertise in the management of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes.\n\nResponsibilities include:\n\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Engineering Project lead for Syringe Filing\n\u2022 The provision of manufacturing input to all capital projects relating to the area.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 All design reviews associated with equipment purchases.\n\u2022 The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.\n\u2022 Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.\n\u2022 Continuous improvement programs\n\u2022 Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-03-07 02:04:02", "url": "http://www.amgen.jobs/xml/26971454/job", "country": "Ireland", "company": "Amgen", "title": "Engineering Projects Manager - Syringe Fill", "reqid": "14217BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971454}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14036BR\nJob Posting Title Sr Mgr Manufacturing - Maintenance Packaging\nCareer Category Maintenance\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Sr. Manager Manufacturing \u2013 Maintenance Packaging\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will report to the Director of Manufacturing & Operations \u2013 Packaging. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations \u2013 Packaging area. Previous experience with maintaining packaging line equipment is a distinct advantage. Working knowledge of equipment from various vendors would also be advantageous.\n\nKey Responsibilities:\n\n\u2022 Manage the Maintenance of the all the Packaging Equipment within the syringe facility while ensuring Manufacturing smooth and consistent running of all equipment in the Packaging facility which has isolator technology.\n\u2022 Strong operating knowledge of pharmaceutical GMP\u2019s and their application to the maintenance function.\n\u2022 Lead in the development of Manufacturing\u2019s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals.\n\u2022 Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment.\n\u2022 Support the plant in the project approval, prioritization, and implementation process.\n\u2022 Develop metrics to support the benchmarking of site, global, and industry.\n\u2022 Develop improvement strategies across the Maintenance function.\n\u2022 Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department.\n\u2022 Assure the appropriate level of training is undertaken for all levels of the Maintenance organization which may involve developing training material.\n\u2022 Responsible for attaining and improving site based metrics targets.\n\u2022 Responsible for recruiting talented staff into Maintenance and setting standards for their performance.\n\u2022 This position will need to complete some travel to the other Amgen sites over the next two years.\n\n* Other functions may be assigned.\nBasic Qualifications Basic Qualifications\n\n\u2022 Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff.\n\u2022 Bachelor\u2019s Degree or combination of education and/or years of experience.\n\u2022 Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable.\nPreferred Qualifications Preferred Qualifications#\n\n\u2022 Knowledge of conflict resolution\n\u2022 Ability to partner with other departments.\n\u2022 Analytical problem solving.\n\u2022 Considerable Organization skills.\n\u2022 Experience in coaching, mentoring and counselling.\n\u2022 Ability to deal with and manage change.\n\u2022 Ability to set goals.\n\u2022 Knowledge of applicable regulatory guidelines\n\u2022 Ability to use company compensation system including mentoring lower management levels when required.\n\u2022 Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.", "date_new": "2012-03-03 20:26:16", "url": "http://www.amgen.jobs/xml/26910351/job", "country": "Ireland", "company": "Amgen", "title": "Sr Mgr Manufacturing - Maintenance Packaging", "reqid": "14036BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 26910351}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14027BR\nJob Posting Title Director Manufacturing - Operations & Packaging\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Director Manufacturing \u2013 Operations & Packaging\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis role will report into the Executive Director Manufacturing and will be responsible for the management of the packaging manufacturing operations, over 4 lines and 2 work centres, at Amgen Dun Laoghaire. The successful Candidate will be responsible for maintenance of the facility, building of the packaging organisation and ensuring the on time delivery of GMP product in a safe and cost effective manner.\nKey Responsibilities:\n\n\u2022  Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage.\n\u2022 Ensure that the Manufacturing \u2013 Operations & Packaging area is staffed with motivated and well trained colleagues and that ongoing programmes are initiated and maintained to ensure flexibility and productivity within the department.\n\u2022 Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture.\n\u2022 A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage.\n\u2022 Develop and maintain an effective organisation through selection, teaching, leadership and development Management.\n\u2022 Define and regularly update our policies for all manufacturing, reflecting prior performance and current needs of the business. Liaise with the relevant supervisors in the course of the day to day activities.\n\u2022 Experience of operations with both high mix and high volume, plus experience with different equipment manufacturers and packaging configurations.\n\u2022 Detailed experience relating to line integration.\n\u2022 The ability to specify the appropriate levels of automation to optimize line efficiency and output quality.\n\u2022 Experience with eliminating glass defects in vials and syringes during packaging operations.\n\u2022 Experience with packaging facility start up and tech transfer programs between different facilities.\n\u2022 Ensure effective two-way communication within the plant, with peers and groups internally and externally.\n\u2022 The ability to adopt a hand\u2019s on approach during start up and commissioning phase.\n\u2022 The capability to undertake significant travel for vendor visits and FAT\u2019s.\n\u2022 Responsibility for maintaining Amgen\u2019s performance management system within the packaging area.\nBasic Qualifications Basic Qualifications:\n\u2022 Degree in Engineering or Science, with a background in manufacturing, quality, process development.\n\u2022 10-15 years experience in managing significant packaging operations in a GMP environment.\n\n\u2022 Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs.\nPreferred Qualifications Preferred Qualifications:\n\n\u2022 BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD)\n\u2022 Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects\n\u2022 Strong technical skills related to scale up\n\u2022 Thorough knowledge of GMP biotechnology manufacturing\n\u2022 Solid understanding and knowledge of cGMPs\n\u2022 Awareness and understanding of quality and regulatory industry trends, policies and guidelines\n\u2022 Proven track record of advancement in an established, high performing organization\n\u2022 Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs\n\u2022 Excellent project management skills with the ability to lead effectively in an highly matrixed organization\n\u2022 Excellent communication skills able to work with and influence executive management\n\u2022 Strong understanding of validation of biopharmaceutical facilities, equipment and process\n\u2022 Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately", "date_new": "2012-03-03 20:25:43", "url": "http://www.amgen.jobs/xml/26910344/job", "country": "Ireland", "company": "Amgen", "title": "Director Manufacturing - Operations & Packaging", "reqid": "14027BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 26910344}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14041BR\nJob Posting Title Sr Mgr Manufacturing - Maintenance Syringe\nCareer Category Maintenance\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Sr. Manager Manufacturing \u2013 Maintenance Syringe\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will report to the Director of Manufacturing & Operations \u2013 Syringe. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations \u2013 Syringe area. Previous experience in maintaining syringe manufacturing and inspection equipment is a distinct advantage. Experience with the use and maintenance of isolator equipment would also be advantageous.\n\nKey Responsibilities:\n\n\u2022 Manage the smooth and consistent running of all equipment in the Syringe facility which has isolator technology.\n\u2022 Strong operating knowledge of pharmaceutical GMP\u2019s and their application to the maintenance function.\n\u2022 Lead in the development of Manufacturing\u2019s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals.\n\u2022 Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment.\n\u2022 Support the plant in the project approval, prioritization, and implementation process.\n\u2022 Develop metrics to support the benchmarking of site, global, and industry.\n\u2022 Develop improvement strategies across the Maintenance function.\n\u2022 Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department.\n\u2022 Assure the appropriate level of training is undertaken for all levels of the Maintenance- Syringe organization which may involve developing training material.\n\u2022 Responsible for attaining and improving site based metrics targets.\n\u2022 Responsible for recruiting talented staff into Maintenance \u2013 Syringe and setting standards for their performance.\n\u2022 This position will need to complete some travel to the other Amgen sites over the next two years.\n\n* Other functions may be assigned.\nBasic Qualifications Basic Qualifications\n\n\u2022 Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff.\n\u2022 Bachelor\u2019s Degree or combination of education and/or years of experience.\n\u2022 Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable.\nPreferred Qualifications Preferred Qualifications#\n\n\u2022 Knowledge of conflict resolution\n\u2022 Ability to partner with other departments.\n\u2022 Analytical problem solving.\n\u2022 Considerable Organization skills.\n\u2022 Experience in coaching, mentoring and counselling.\n\u2022 Ability to deal with and manage change.\n\u2022 Ability to set goals.\n\u2022 Knowledge of applicable regulatory guidelines\n\u2022 Ability to use company compensation system including mentoring lower management levels when required.\n\u2022 Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.", "date_new": "2012-03-03 20:25:23", "url": "http://www.amgen.jobs/xml/26910341/job", "country": "Ireland", "company": "Amgen", "title": "Sr Mgr Manufacturing - Maintenance Syringe", "reqid": "14041BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 26910341}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14028BR\nJob Posting Title Dir Manufacturing - Syringe\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Director Manufacturing - Syringe\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis role will report into the Executive Director Manufacturing and will be responsible for the manufacturing of syringes at the Amgen Dun Laoghaire Site. The successful candidate will be responsible for the maintenance of the facility and for building an organization that ensures on time delivery of GMP product in a safe and cost effective manner.\n\nKey Responsibilities:\n\n\u2022  Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage.\n\u2022 Ensure that the Manufacturing \u2013 Syringe area is staffed with motivated and well trained colleagues and that ongoing programmes are initiated and maintained to ensure flexibility and productivity within the department.\n\u2022 Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture.\n\u2022 A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage.\n\u2022 Develop and maintain an effective organisation through selection, teaching, leadership and development Management.\n\u2022 Define and regularly update our policies for all manufacturing, reflecting prior performance and current needs of the business. Liaise with the relevant supervisors in the course of the day to day activities.\n\u2022  Experience with syringe facility start up and tech transfer programs between different facilities.\n\u2022 Experience of syringe inspection operations with previous experience of training of staff in this area an advantage.\n\u2022 Detailed experience relating to all aspects of line integration.\n\u2022 A detailed understanding of the automation requirements necessary to optimize line efficiency and output quality.\n\u2022 Experience with eliminating glass defects in syringes during filling and inspection operations.\n\u2022 Prepares and submit annual expenditure budgets and monitor actual performance against these budgets, taking corrective action where necessary\n\u2022 Ensure effective two-way communication within the plant, with peers and groups internally and externally.\n\u2022 The ability to adopt a hand\u2019s on approach during start up and commissioning phase.\n\u2022 The capability to undertake significant travel for vendor visits and FAT\u2019s.\n\u2022 Responsibility for maintaining Amgen\u2019s performance management system within the syringe filling area.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Degree educated with significant relevant experience\n\u2022 Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs.\nPreferred Qualifications Preferred Qualifications:\n\n\u2022 BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD)\n\u2022 Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects\n\u2022 Strong technical skills related to scale up\n\u2022 Thorough knowledge of GMP biotechnology manufacturing\n\u2022 Solid understanding and knowledge of cGMPs\n\u2022 Awareness and understanding of quality and regulatory industry trends, policies and guidelines\n\u2022 Proven track record of advancement in an established, high performing organization\n\u2022 Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs\n\u2022 Excellent project management skills with the ability to lead effectively in an highly matrixed organization\n\u2022 Excellent communication skills able to work with and influence executive management\n\u2022 Strong understanding of validation of biopharmaceutical facilities, equipment and process\n\u2022 Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately", "date_new": "2012-03-03 20:24:47", "url": "http://www.amgen.jobs/xml/26910336/job", "country": "Ireland", "company": "Amgen", "title": "Dir Manufacturing - Syringe", "reqid": "14028BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 26910336}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13864BR\nJob Posting Title HVAC & Utilities Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Job Title HVAC/Utilities Validation Engineer\n\nJob Description HVAC/Utilities Validation Engineer\n\nAs a HVAC/Utilities validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the HVAC/Utilities for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.\n\nMajor Responsibilities\n\n\u2022 Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for HVAC and Utilities for a Sterile Fill Finish Facility.\n\u2022 Ensure all aspects of HVAC/Clean Utility Validation adhere to required policies and procedures, including safety and training.\n\u2022 Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.\n\u2022 Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.\n\u2022 Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for HVAC, Clean Steam, Process Air and WFI Systems.\n\u2022 Participate as required in project activities.\n\u2022 Review of Existing Site Systems to ensure compliance.\n\u2022 Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS\u2019s), Factory Acceptance Tests (Fat\u2019s) to ensure the QBD principles are being followed.\n\u2022 Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents\n\u2022 Collate and report on relevant Validation data/matrices.\n\u2022 Assist in deviation and exception resolution and root cause analysis.\n\u2022 Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.\n\u2022 Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.\nBasic Qualifications Experience/Background\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.\n\u2022 Minimum 4-6 years experience in a similar role.\n\n\nEducation Requirements\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.", "date_new": "2012-02-13 19:30:14", "url": "http://www.amgen.jobs/xml/26495641/job", "country": "Ireland", "company": "Amgen", "title": "HVAC & Utilities Validation Engineer", "reqid": "13864BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26495641}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13863BR\nJob Posting Title Sterile Filling & Inspection Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Job Title Sterile Filling and Inspection Validation Engineer\n\nJob Description Sterile Filling and Inspection Validation Engineer\n\nAs a Sterile Filling and Inspction validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Sterile Syringe Filling and Inspection for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.\n\nMajor Responsibilities\n\n\u2022 Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Sterile Syringe Filling, Isolator and Inspection for a Sterile Fill Finish Facility.\n\u2022 Ensure all aspects of Syringe Filling, Isolator and Inspection Validation adhere to required policies and procedures, including safety and training.\n\u2022 Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.\n\u2022 Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for Syringe Filling, Isolator and Inspection Systems.\n\u2022 Participate as required in project activities.\n\u2022 Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS\u2019s), Factory Acceptance Tests (Fat\u2019s) to ensure the QBD principles are being followed.\n\u2022 Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents\n\u2022 Collate and report on relevant Validation data/matrices.\n\u2022 Assist in deviation and exception resolution and root cause analysis.\n\u2022 Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.\nBasic Qualifications Experience/Background\n\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.\nSyringe Filling and Isolator Technology Experience essential\nAutomated Inspection Technology Experience an advantage\n\u2022 Minimum 4-6 years experience in a similar role.\n\n\nEducation Requirements\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.", "date_new": "2012-02-13 19:30:03", "url": "http://www.amgen.jobs/xml/26495637/job", "country": "Ireland", "company": "Amgen", "title": "Sterile Filling & Inspection Validation Engineer", "reqid": "13863BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26495637}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13867BR\nJob Posting Title Sr Packaging Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Job Title Senior Packaging Validation Engineer\n\nJob Description Senior Packaging Validation Engineer\n\nAs a senior Packaging validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Packaging and Labelling and Shipping of Sterile Filled Syringes and Vials are in compliance with Division Quality System requirements and recognised international standards.\n\nMajor Responsibilities\n\n\u2022 Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations.\n\u2022 Leading the team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training.\n\u2022 Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.\n\u2022 Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.\n\u2022 Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.\n\u2022 Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS\u2019s), Factory Acceptance Tests (Fat\u2019s) to ensure the QBD principles are being followed.\n\u2022 Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents\n\u2022 Collate and report on relevant Validation data/matrices.\n\u2022 Assist in deviation and exception resolution and root cause analysis.\n\u2022 Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.\n\u2022 Participate as required in project activities.\n\u2022 Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.\nBasic Qualifications Experience/Background\n\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.\n\u2022 Minimum 5-10 years experience in a similar role.\nPreferred Qualifications Overall knowledge in equipment, facility, cleaning and steaming validation. Technical understanding of pharmaceutical/biotechnology unit operations. Project management skills Skilled at initiation and leading cross functional teams Database and spreadsheet application skills Strong technical writing and oral communication skills Facilitation and presentation skills Experience with leading complex investigations and CAPAs Ability to evaluate compliance issues and interact with regulatory inspectors", "date_new": "2012-02-13 19:29:10", "url": "http://www.amgen.jobs/xml/26495601/job", "country": "Ireland", "company": "Amgen", "title": "Sr Packaging Validation Engineer", "reqid": "13867BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26495601}]