Amgen Jobshttp://www.amgen.jobs2012-05-26 19:48:34.369302IRLDun LaoghaireAuto req 15464BR Job Posting Title Sr Associate QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Job Description Position Title: QA Snr Associate Reports to: QP Group/Division: Amgen Dun Laoghaire Department: QA Shift Yes 24/5 Position Summary: This 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. The QA Snr Associates duties are as follows; • Compiles QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses. • Review and approve Master Batch Records • Review non conformances for completeness • Prepare the agenda for Site Quality Review Team and submits non conformances for review/discussion. • Prepares the SQRT minutes. • Assigns expiry date to products. • Prepare deviation trend reports bi annually to establish any evident trends. • Schedules products to be placed on the stability program • Status changes and yields product on the computer system • Prepares non conformance reports for shipments as required • Tracks CAPA’s detailed in non conformance reports • Writes, reviews and approves Standard Operating Procedures in accordance with Amgen Policies • Prepares Monthly Metrics. • Ensure compliance with Amgen procedures • Performs Quality Audits to ensure compliance with cGMPs • Maintains databases and other informational systems as necessary. • Prepares the KPI reports as required. • Complies with responsibilities as outlined in the site Safety Statement section 3.6. • Performs all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures. • Participates in a learning and development programme which will include goal setting, annual performance reviews and individual development plans. • Is a champion for safe working practices and safety initiatives within their functional area. Basic Qualifications Education: Third level qualification, preferably to degree level, in a Science discipline. Experience: Minimum three years industrial experience or equivalent Preferred 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 skills2012-05-17 20:58:26IrelandAmgenNone15464BRNoneDun Laoghaire, IRL28771078http://www.amgen.jobs/xml/28771078/jobIRLDun LaoghaireAuto req 15363BR Job Posting Title Mgr Maintenance Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Maintenance Manager – Level 5 Amgen Dun Laoghaire - Dublin This 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. •Carry out fault investigation and problem analysis for maintenance related issues, identify alternative solutions, prepare proposals for modifications or improvements and execute/trial as necessary •Provide input at various project stages to review maintainability – 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. •Administer control and develop PM System, provide technical input for developing PM’s and for other maintenance aspects of maintenance documentation; assisting with equipment/process fault identification and improvements. •Administer and control planned maintenance systems ensuring work orders are issued, completed and returned on time, running reports, analysing trends and issuing proactive worksheets. •Provide technical input into preparation and issue of SOP’s; corrective action tracking; operation and maintenance manuals. •Assist with preparation and co-ordination of shutdown activities, manage and review activity schedules and produce summary reports •Conduct 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. •Participation in ‘call-out system’ to cover Engineering response (out of normal hours, management of weekend maintenance activities Basic Qualifications •Bachelor's degree in Engineering, Science or related field. •Significant relevant work experience within operations/manufacturing environment •Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) •Established expertise in multiple areas of engineering technology. Preferred Qualifications •Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope. •Working knowledge of financial analysis tools' and appreciation for project cost development •Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation. •Written communication including technical writing. •Team leadership skills: Management, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-04-27 20:21:28IrelandAmgenNone15363BRNoneDun Laoghaire, IRL28241185http://www.amgen.jobs/xml/28241185/jobIRLField BasedAuto req 14626BR Job Posting Title Regional Medical Liaison Career Category Sales Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Field Based Amgen 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. The 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. The RML will communicate complex cutting edge, scientific information and research concepts to healthcare professionals and support Amgen sponsored research. The RML will represent Amgen medical department in the fiels within the Bone Therapeuticc Area in compliance with local and Amgen regulatory standards. Basic 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. Preferred Qualifications Advanced degree (e.g. PhD, MD) preferred or strong demonstration of equivalent combination of relevant educational and professional training. Experience: - Working in the bone field - Setting up and running research studies in a hosspital environment - Knowledge of regulatory affairs, drug safety, legal and compliance environment (IPHA OR ABPI) - Network of customer contacts in bone field - PhD in a bioscience discipline2012-04-13 02:24:03IrelandAmgenNone14626BRNoneField Based, IRL27868810http://www.amgen.jobs/xml/27868810/jobIRLCorkAuto req 14214BR Job Posting Title Engineering Projects Mgr Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Cork Dublin Field Based Dun Laoghaire Amgen Job Description Engineer Project Manager - Packaging Amgen Dun Laoghaire - Dublin Overview: This 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 –Packaging. 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. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Engineering Project lead for Packaging • The provision of manufacturing input to all capital projects relating to the area. • The definition and scoping of all process improvement activities relating to the area. • All design reviews associated with equipment purchases. • The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad. • Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site. • Continuous improvement programs • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Significant experience large project related activities including GMP qualification experience.2012-04-04 03:03:14IrelandAmgenNone14214BRNoneCork, IRL27630466http://www.amgen.jobs/xml/27630466/jobIRLDublinAuto req 13504BR Job Posting Title Sr Mgr Manufacturing - Vial Fill Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Manager Manufacturing - Vial Fill Amgen Dun Laoghaire - Dublin Overview: This position will report to the Director of Manufacturing. The ideal candidate will provide strong management and leadership in the Manufacturing – vial fill facility. Key Responsibilities: • Manage the Vial Fill Manufacturing Facility department. • Lead in the development of long range planning (LRP) to maintain the highest level of productivity. • Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals. • Develop, maintain, and justify the departments’ budgets. • Responsible for ensuring that all manufacturing is carried out under GMP conditions and in a safe working environment. • Support the plant in the project approval, prioritization, and implementation process. • Develop metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based on the benchmarking data. • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the manufacturing department. • Assure the appropriate level of training is undertaken for all levels of the manufacturing syringe organization which may involve developing training material. • Responsible for attaining and improving site based metrics targets. • Responsible for recruiting talented staff into the facility and setting standards for their performance. • This position will need to complete some travel to the other Amgen sites over the next two years. * Other functions may be assigned. Basic Qualifications Basic Qualifications • Typically 8+ years of experience in facilities management position. With typically 4+ years experience supervising technical staff • Bachelor’s Degree or combination of education and/or years of experience. Preferred Qualifications Preferred Qualifications • Knowledge of conflict resolution • Ability to partner with other departments. • Analytical problem solving. • Considerable Organization skills. • Experience in coaching, mentoring and counselling. • Ability to deal with and manage change. • Ability to set goals. • Knowledge of applicable regulatory guidelines • Ability to use company compensation system including mentoring lower management levels when required. • Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-03-28 21:28:53IrelandAmgenNone13504BRNoneDublin, IRL27464075http://www.amgen.jobs/xml/27464075/jobIRLDublinAuto req 14509BR Job Posting Title Engineer - Packaging Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Packaging Engineer Amgen Job Description Packaging Engineer - Process Development This 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. Knowledge of primary and secondary packaging systems and processes, packaging equipment, components and packaging processes, material science and quality system is essential to the position. The 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. This position is responsible and accountable for the following: 1) Evaluation, recommendation and selection of primary and secondary packaging materials, equipment , and vendors 2) Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials / equipment. 3) Write Technical Specifications, SOP’s and Bill of Materials 4) Representing Process Development in Drug Product and Global Operation Teams as required 5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes 6) Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes 7) Ensures cGMP and regulatory compliance are met at all times 8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes 9) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. 10) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems in a timely manner. 11) Excellent problem solving and RCA skills. Excellent report writing skills. 12) Support the NPI process 13) Effectively review and close out non conformances by CAPA 14) Participate in FAT, SAT Demonstrated Competencies/Skills: 1) Independent thinker with demonstrated skills working in teams or leading project teams 2) Strong Interpersonal and communication skills 3) Ability to multi-task and manage tight timelines 4) Excellent report writing skills 5) Proven problem solving skills and indepth knowledge of problem solving methodologies 6) Knowledge of Regulatory environment 7) Flexible and adaptive – this position will involve travel and shift work. Basic Qualifications Basic Qualifications • Degree / diploma in engineering discipline with 5 + years relevant pharmaceutical packaging experience Or • Degree / diploma in packaging technology / materials sciences with 5 + years relevant pharmaceutical packaging experience2012-03-22 18:49:02IrelandAmgenNone14509BRNoneDublin, IRL27320620http://www.amgen.jobs/xml/27320620/jobIRLDun LaoghaireAuto req 14194BR Job Posting Title Training and Development Manager Career Category Training Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description The Training and Development Manager will be responsible for developing partnerships with key clients while influencing and establishing operating standards and practices. To be successful in this role you will need to complete the following: • Under minimal supervision, partners with the client to apply human performance theory and needs analysis skills to analyze performance issues and identify solutions that support business needs. • When a training need is identified, can utilize instructional design and adult learning methodologies to design and develop solutions in a variety of delivery formats. • Manages assigned projects. • Works with internal clients to manage their curricula and assignments and ensure all training materials are integrated with Amgen’s learning management system per defined business processes. • Supports the gathering and evaluation of metrics that ensure the effectiveness of performance solutions and training materials. • Serves as an internal client’s first point of contact for performance and training questions. • Leads global training forum for client function and represents client during Operations global governance and prioritization processes. • Writes instructional materials, leader’s guides, etc, and able to modify existing material. • Develops and conducts Train-the-Trainer classes/support as needed. • Works with audit response teams to ensure appropriate actions are taken. • Provides proactive strategic planning to client regarding future performance needs and global curricula projects. • Serves on sustainment steering committee for applicable global programs. • Ensures that training content is current and reflects all technical and compliance standards. Basic Qualifications • Bachelors Degree or comparable professional experience in Instructional Design, Human Performance Technology, Life Sciences, or Business • 5+ years experience as a performance consultant, instructional designer, and/or curriculum developer • Knowledge of adult learning theory, instructional design, performance consulting, and needs analysis • Experience using ADDIE or other instructional design methodology in the creation of training materials • Experience supporting and/or creating materials for on-the-job training • 2+ year project management (managing projects, defining scope, overseeing budget, tracking milestones) • Travel, up to 10% Preferred Qualifications • 2 years experience in Microsoft Word, PowerPoint, and Excel • Any experience with business processes surrounding the use of learning management or training systems (i.e., SumTotal, ISOtrain) • Experience working in a regulated environment (FDA, OSHA, NRC, etc.) • 1 year experience with Visio and MS Project • eLearning design experience and knowledge of online performance support tools • Ability to work with staff across all levels of an organization • Effective communication and writing skills2012-03-21 18:36:06IrelandAmgenNone14194BRNoneDun Laoghaire, IRL27297538http://www.amgen.jobs/xml/27297538/jobIRLDun LaoghaireAuto req 14198BR Job Posting Title Sr Associate Training & Development Career Category Training Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen 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. FUNCTIONS • Responsible for effective delivery of training to client group. Includes classroom, one-on-one, and on-the-job training. Could also ensure effective delivery of eLearning courses. • Works closely with assigned clients, in their work environment, to understand and assess specific training needs. • Communicates client training needs to local training management. • Responsible for delivery of solutions to meet the specific training needs of assigned clients. • Responsible for effective delivery of cGMP and other regulatory training, as required by client group. • Delivers initial and ongoing training for new hires and transfers. Facilitates transition of new hires/transfer-ins from training environment to work environment. • Facilitates the assignment and un-assignment of training courses/modules for staff members. • Provides guidance to client on compliance and regulatory issues. • Participates and /or leads inspections activities. • Coaches and develops SME/ certified trainers within client area to be effective trainers. • Assists in review of human error”-related incidents: determine need for additional or modified training interventions for affected staff. • May provide input into the implementation of corporate core curricula and standard learning processes. • May participate on global training teams as assigned. • May include small scale training design projects to meet local client needs. Basic Qualifications Master’s degree OR Bachelor’s degree & 2 years of of experience directly related to the job OR Associate’s degree & 6 years of experience directly related to the job. Preferred Qualifications • Strong customer service orientation and influencing skills to work directly with client staff and identifying performance needs. • Working knowledge on computer software programs including: Word, Excel, and Power Point. • Works directly with client in delivering training. • Demonstrates understanding of Amgen’s business and culture, and ability to work effectively with staff at all levels • Technical competency commensurate with assigned area(s) of responsibility • Regulatory compliance competency commensurate with assigned area(s) of responsibility Skilled in process modeling and troubleshooting • Basic project management skills • Good interpersonal, group facilitation and presentation skills • Able to accomplish results through own work and through influencing client staff members and management2012-03-21 18:35:48IrelandAmgenNone14198BRNoneDun Laoghaire, IRL27297532http://www.amgen.jobs/xml/27297532/jobIRLDublinAuto req 14039BR Job Posting Title 2 x Manager Manufacturing - Syringe Filling & Inspection Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Manager Manufacturing –Syringe Filing & Inspection Amgen Dun Laoghaire - Dublin Overview: The Manager Manufacturing – Syringe Filling & inspection reports to the Sr Manager Manufacturing – 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. Responsibilities include: • Responsible for filling and inspection line output during their shift. • Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment. • Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc. • Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment. • Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment. • Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met. • Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits. • Prepared to work on a shift basis, leading a manufacturing team. • Able to travel to other sites within the organization for certain time periods. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering or Science Relevant Experience • Typically 5 – 8 years experience in an aseptic pharmaceutical environment.2012-03-07 02:05:41IrelandAmgenNone14039BRNoneDublin, IRL26971935http://www.amgen.jobs/xml/26971935/jobIRLDublinAuto req 14042BR Job Posting Title Sr Engineer - Packaging (Line Owner) Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Engineer – Packaging (Line Owner) Level 5 Amgen Dun Laoghaire - Dublin Overview: This 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 –Packaging. 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. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Monitoring of day to day manufacturing operations. • Data trend analysis for all performance aspects of a packaging line. • The definition and scoping of all process improvement activities relating to the area. • Solving or escalating problems as appropriate. • All design reviews associated with equipment purchases. • Troubleshooting performance trends. • Risk assessments and mitigation projects relating to line performance. • Support of new product introductions and supporting introduction of new equipment. • The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad. • Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site. • Continuous improvement programs and all performance improvement projects. • Review and approval of changes to operating procedures and the change control process relating to the line. • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. • Supporting non conformance investigation. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Significant experience large project related activities including GMP qualification experience.2012-03-07 02:05:14IrelandAmgenNone14042BRNoneDublin, IRL26971791http://www.amgen.jobs/xml/26971791/jobIRLDublinAuto req 14037BR Job Posting Title 4 x Manager Manufacturing - Packaging Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Manager Manufacturing – Packaging Amgen Dun Laoghaire - Dublin Overview: The Manager Manufacturing – Packing reports to the Sr Manager Manufacturing – 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. Responsibilities include: • Responsible for filling and inspection packaging line output during their shift. • Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment. • Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc. • Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment. • Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment. • Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met. • Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits. • Prepared to work on a shift basis, leading a manufacturing team. • Able to travel to other sites within the organization for certain time periods. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering or Science Relevant Experience • Typically 5 – 8 years experience in an aseptic pharmaceutical environment. • Previous experience working on packaging lines in a man management role is a distinct advantage.2012-03-07 02:05:13IrelandAmgenNone14037BRNoneDublin, IRL26971785http://www.amgen.jobs/xml/26971785/jobIRLDublinAuto req 14038BR Job Posting Title Senior Engineer - Industrial Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Engineer – Industrial Amgen Dun Laoghaire - Dublin Overview: This 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 – Syringe. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Performing resource assessments for each area and developing resource standards and labour models • Data trend analysis for all performance aspects of the area. • The definition and scoping of all process improvement activities relating to the area. • Solving or escalating problems as appropriate. • Leading improvement initiatives in areas of waste reduction, right first time approaches and productivity improvement. • Troubleshooting performance trends. • Risk assessments and mitigation projects relating to line performance. • Performing resource gap analysis for machinery and labour and developing strategies to close these gaps. • Continuous improvement programs and all performance improvement projects. • Working with the operational excellence group in implementing OE methods, mentoring project leads and facilitating process improvement teams. • Review and approval of changes to operating procedures and the change control process relating to the line. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Qualification in Lean and 6-sigma methodologies would be an advantage. • Significant experience large project related activities including GMP qualification experience.2012-03-07 02:05:06IrelandAmgenNone14038BRNoneDublin, IRL26971749http://www.amgen.jobs/xml/26971749/jobIRLDublinAuto req 14211BR Job Posting Title 2 x Sr Associate Tech Engineering - Syringe Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Associate Tech Engineer - Syringe Amgen Dun Laoghaire - Dublin Overview: The 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’s new syringe manufacturing facility. On completion of the start up, this position will transition to providing technical support to the manufacturing facility. Key Responsibilities: During start up the individual will execute all project activities associated with start up of the syringe line, including but not limited to: • Participation in equipment design reviews. • Development and execution of FAT, SAT, IOQ protocols. • Development, revision and review of technical documents such as SOP’s, job plans etc. • A willingness to spend time abroad over the next 2 years. • Ensuring that work is completed in a safe manner under GMP conditions and in accordance with applicable Amgen procedures. During routine manufacturing operations, the individual will provide technical support to the syringe line by: • Ensuring that daily output and compliance requirements are met. • Tracking equipment and process performance to ensure compliance with operating standards. • Implementing corrective actions when deviations from standard are detected. • Ensuring that maintenance personnel have clear definition/guidance when equipment problems are encountered and improvement is required. • Working to investigate, resolve and closeout all issues relating to NC’s, CAPA’s, process deviations. • Owning manufacturing area SOP’s and change control reports. Basic Qualifications Basic Qualifications: • Degree in Engineering/Science or equivalent • Significant relevant process engineering industry experience Key competencies: • Analytical thinking • Focus on quality • Drive for results • Initiative • Planning and prioritisation • Teamwork and Co-operation Preferred Qualifications Preferred Qualifications. • Excellent written and verbal communication skills • Knowledge of applicable Regulatory requirements • Experience with Regulatory inspections desirable • Experience leading cross-functional teams desirable • Experience working with teams and influencing decisions2012-03-07 02:04:45IrelandAmgenNone14211BRNoneDublin, IRL26971668http://www.amgen.jobs/xml/26971668/jobIRLDublinAuto req 14219BR Job Posting Title 2 x Manager Manufacturing – Syringe, Component Prep & Formulation Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Manager Manufacturing – Syringe, Component Prep & Formulation Amgen Dun Laoghaire - Dublin Overview: The Manager Manufacturing – Syringe, Component Prep & Formulation reports to the Sr Manager Manufacturing – 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. Responsibilities include: • Responsible for filling and inspection line output during their shift. • Responsible for ensuring that all staff operate within GMP’s and maintaining a safe work environment. • Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc. • Responsible for ensuring that all staff operates within GMP’s and maintaining a safe work environment. • Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment. • Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met. • Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits. • Prepared to work on a shift basis, leading a manufacturing team. • Able to travel to other sites within the organization for certain time periods. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering or Science Relevant Experience • Typically 5 – 8 years experience in an aseptic pharmaceutical environment. • Previous experience of management of Syringe filling and inspection operations is a distinct advantage.2012-03-07 02:04:18IrelandAmgenNone14219BRNoneDublin, IRL26971519http://www.amgen.jobs/xml/26971519/jobIRLDublinAuto req 14217BR Job Posting Title Engineering Projects Manager - Syringe Fill Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Engineer Project Manager - Syringe Filling Amgen Dun Laoghaire - Dublin Overview: This 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 –Syringe. 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. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Engineering Project lead for Syringe Filing • The provision of manufacturing input to all capital projects relating to the area. • The definition and scoping of all process improvement activities relating to the area. • All design reviews associated with equipment purchases. • The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad. • Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site. • Continuous improvement programs • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Significant experience large project related activities including GMP qualification experience.2012-03-07 02:04:02IrelandAmgenNone14217BRNoneDublin, IRL26971454http://www.amgen.jobs/xml/26971454/jobIRLDun LaoghaireAuto req 14036BR Job Posting Title Sr Mgr Manufacturing - Maintenance Packaging Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Sr. Manager Manufacturing – Maintenance Packaging Amgen Dun Laoghaire - Dublin Overview: This position will report to the Director of Manufacturing & Operations – Packaging. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations – Packaging area. Previous experience with maintaining packaging line equipment is a distinct advantage. Working knowledge of equipment from various vendors would also be advantageous. Key Responsibilities: • 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. • Strong operating knowledge of pharmaceutical GMP’s and their application to the maintenance function. • Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals. • Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment. • Support the plant in the project approval, prioritization, and implementation process. • Develop metrics to support the benchmarking of site, global, and industry. • Develop improvement strategies across the Maintenance function. • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department. • Assure the appropriate level of training is undertaken for all levels of the Maintenance organization which may involve developing training material. • Responsible for attaining and improving site based metrics targets. • Responsible for recruiting talented staff into Maintenance and setting standards for their performance. • This position will need to complete some travel to the other Amgen sites over the next two years. * Other functions may be assigned. Basic Qualifications Basic Qualifications • Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff. • Bachelor’s Degree or combination of education and/or years of experience. • Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable. Preferred Qualifications Preferred Qualifications# • Knowledge of conflict resolution • Ability to partner with other departments. • Analytical problem solving. • Considerable Organization skills. • Experience in coaching, mentoring and counselling. • Ability to deal with and manage change. • Ability to set goals. • Knowledge of applicable regulatory guidelines • Ability to use company compensation system including mentoring lower management levels when required. • Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-03-03 20:26:16IrelandAmgenNone14036BRNoneDun Laoghaire, IRL26910351http://www.amgen.jobs/xml/26910351/jobIRLDun LaoghaireAuto req 14027BR Job Posting Title Director Manufacturing - Operations & Packaging Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Director Manufacturing – Operations & Packaging Amgen Dun Laoghaire - Dublin Overview: This 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. Key Responsibilities: • Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage. • Ensure that the Manufacturing – 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. • Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture. • A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage. • Develop and maintain an effective organisation through selection, teaching, leadership and development Management. • 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. • Experience of operations with both high mix and high volume, plus experience with different equipment manufacturers and packaging configurations. • Detailed experience relating to line integration. • The ability to specify the appropriate levels of automation to optimize line efficiency and output quality. • Experience with eliminating glass defects in vials and syringes during packaging operations. • Experience with packaging facility start up and tech transfer programs between different facilities. • Ensure effective two-way communication within the plant, with peers and groups internally and externally. • The ability to adopt a hand’s on approach during start up and commissioning phase. • The capability to undertake significant travel for vendor visits and FAT’s. • Responsibility for maintaining Amgen’s performance management system within the packaging area. Basic Qualifications Basic Qualifications: • Degree in Engineering or Science, with a background in manufacturing, quality, process development. • 10-15 years experience in managing significant packaging operations in a GMP environment. • Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs. Preferred Qualifications Preferred Qualifications: • BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD) • Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects • Strong technical skills related to scale up • Thorough knowledge of GMP biotechnology manufacturing • Solid understanding and knowledge of cGMPs • Awareness and understanding of quality and regulatory industry trends, policies and guidelines • Proven track record of advancement in an established, high performing organization • Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs • Excellent project management skills with the ability to lead effectively in an highly matrixed organization • Excellent communication skills able to work with and influence executive management • Strong understanding of validation of biopharmaceutical facilities, equipment and process • Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately2012-03-03 20:25:43IrelandAmgenNone14027BRNoneDun Laoghaire, IRL26910344http://www.amgen.jobs/xml/26910344/jobIRLDun LaoghaireAuto req 14041BR Job Posting Title Sr Mgr Manufacturing - Maintenance Syringe Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Sr. Manager Manufacturing – Maintenance Syringe Amgen Dun Laoghaire - Dublin Overview: This position will report to the Director of Manufacturing & Operations – Syringe. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations – 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. Key Responsibilities: • Manage the smooth and consistent running of all equipment in the Syringe facility which has isolator technology. • Strong operating knowledge of pharmaceutical GMP’s and their application to the maintenance function. • Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals. • Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment. • Support the plant in the project approval, prioritization, and implementation process. • Develop metrics to support the benchmarking of site, global, and industry. • Develop improvement strategies across the Maintenance function. • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department. • Assure the appropriate level of training is undertaken for all levels of the Maintenance- Syringe organization which may involve developing training material. • Responsible for attaining and improving site based metrics targets. • Responsible for recruiting talented staff into Maintenance – Syringe and setting standards for their performance. • This position will need to complete some travel to the other Amgen sites over the next two years. * Other functions may be assigned. Basic Qualifications Basic Qualifications • Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff. • Bachelor’s Degree or combination of education and/or years of experience. • Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable. Preferred Qualifications Preferred Qualifications# • Knowledge of conflict resolution • Ability to partner with other departments. • Analytical problem solving. • Considerable Organization skills. • Experience in coaching, mentoring and counselling. • Ability to deal with and manage change. • Ability to set goals. • Knowledge of applicable regulatory guidelines • Ability to use company compensation system including mentoring lower management levels when required. • Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-03-03 20:25:23IrelandAmgenNone14041BRNoneDun Laoghaire, IRL26910341http://www.amgen.jobs/xml/26910341/jobIRLDun LaoghaireAuto req 14028BR Job Posting Title Dir Manufacturing - Syringe Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Director Manufacturing - Syringe Amgen Dun Laoghaire - Dublin Overview: This 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. Key Responsibilities: • Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage. • Ensure that the Manufacturing – 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. • Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture. • A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage. • Develop and maintain an effective organisation through selection, teaching, leadership and development Management. • 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. • Experience with syringe facility start up and tech transfer programs between different facilities. • Experience of syringe inspection operations with previous experience of training of staff in this area an advantage. • Detailed experience relating to all aspects of line integration. • A detailed understanding of the automation requirements necessary to optimize line efficiency and output quality. • Experience with eliminating glass defects in syringes during filling and inspection operations. • Prepares and submit annual expenditure budgets and monitor actual performance against these budgets, taking corrective action where necessary • Ensure effective two-way communication within the plant, with peers and groups internally and externally. • The ability to adopt a hand’s on approach during start up and commissioning phase. • The capability to undertake significant travel for vendor visits and FAT’s. • Responsibility for maintaining Amgen’s performance management system within the syringe filling area. Basic Qualifications Basic Qualifications: • Degree educated with significant relevant experience • Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs. Preferred Qualifications Preferred Qualifications: • BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD) • Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects • Strong technical skills related to scale up • Thorough knowledge of GMP biotechnology manufacturing • Solid understanding and knowledge of cGMPs • Awareness and understanding of quality and regulatory industry trends, policies and guidelines • Proven track record of advancement in an established, high performing organization • Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs • Excellent project management skills with the ability to lead effectively in an highly matrixed organization • Excellent communication skills able to work with and influence executive management • Strong understanding of validation of biopharmaceutical facilities, equipment and process • Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately2012-03-03 20:24:47IrelandAmgenNone14028BRNoneDun Laoghaire, IRL26910336http://www.amgen.jobs/xml/26910336/jobIRLDublinAuto req 13864BR Job Posting Title HVAC & Utilities Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Job Title HVAC/Utilities Validation Engineer Job Description HVAC/Utilities Validation Engineer As 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. Major Responsibilities • Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for HVAC and Utilities for a Sterile Fill Finish Facility. • Ensure all aspects of HVAC/Clean Utility Validation adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures. • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for HVAC, Clean Steam, Process Air and WFI Systems. • Participate as required in project activities. • Review of Existing Site Systems to ensure compliance. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed. • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents • Collate and report on relevant Validation data/matrices. • Assist in deviation and exception resolution and root cause analysis. • Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader. • Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant. Basic Qualifications Experience/Background • A third level qualification in Science, Engineering or a relevant Quality discipline. • Minimum 4-6 years experience in a similar role. Education Requirements • A third level qualification in Science, Engineering or a relevant Quality discipline.2012-02-13 19:30:14IrelandAmgenNone13864BRNoneDublin, IRL26495641http://www.amgen.jobs/xml/26495641/jobIRLDublinAuto req 13863BR Job Posting Title Sterile Filling & Inspection Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Job Title Sterile Filling and Inspection Validation Engineer Job Description Sterile Filling and Inspection Validation Engineer As 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. Major Responsibilities • 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. • Ensure all aspects of Syringe Filling, Isolator and Inspection Validation adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for Syringe Filling, Isolator and Inspection Systems. • Participate as required in project activities. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed. • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents • Collate and report on relevant Validation data/matrices. • Assist in deviation and exception resolution and root cause analysis. • Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader. Basic Qualifications Experience/Background • A third level qualification in Science, Engineering or a relevant Quality discipline. Syringe Filling and Isolator Technology Experience essential Automated Inspection Technology Experience an advantage • Minimum 4-6 years experience in a similar role. Education Requirements • A third level qualification in Science, Engineering or a relevant Quality discipline.2012-02-13 19:30:03IrelandAmgenNone13863BRNoneDublin, IRL26495637http://www.amgen.jobs/xml/26495637/jobIRLDublinAuto req 13867BR Job Posting Title Sr Packaging Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Job Title Senior Packaging Validation Engineer Job Description Senior Packaging Validation Engineer As 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. Major Responsibilities • Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations. • Leading the team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures. • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed. • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents • Collate and report on relevant Validation data/matrices. • Assist in deviation and exception resolution and root cause analysis. • Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader. • Participate as required in project activities. • Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant. Basic Qualifications Experience/Background • A third level qualification in Science, Engineering or a relevant Quality discipline. • Minimum 5-10 years experience in a similar role. Preferred 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 inspectors2012-02-13 19:29:10IrelandAmgenNone13867BRNoneDublin, IRL26495601http://www.amgen.jobs/xml/26495601/job