[{"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": "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": "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}]