Manufacturing Specialist
4 hours ago
Job Summary: An exciting and rare opportunity has presented for an Aseptic Process Owner Lead at Amgen, Dublin. This is a senior role in the organisation and requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping. The Site Aseptic Process Owner Lead will continue to build on the site and network aseptic processing knowledge and represent the Dublin site at a global level across the Amgen manufacturing network. As the Site Aseptic Process Lead you will be an established professional who is a self-starter, capable of applying advanced process knowledge and creativity to complete complex assignments related to aseptic operations. You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from an aseptic operations perspective. Primary responsibilities: Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance aseptic operations. Leading and/or providing input to strategic initiatives that will improve and develop Manufacturing processes for the future including Contamination Control and Aseptic Process Simulations (APS) Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology. Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends (Personnel and Environmental Monitoring), including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are conducted and actionable CAPAs, to prevent future reoccurrence, are implemented within agreed timelines What you need to apply: Bachelor's degree in Microbiology or related discipline with 10 + years' experience in the pharmaceutical industry Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products. Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner Excellent Decision-Making skills and confidence to challenge others respectfully and professionally on decisions that impact the manufacturing area Proactive and works well with others in a collaborative, fast-paced goal-driven environment Interacts well with diverse groups (Manufacturing, Validation, Engineering, Quality etc) and maintains strong working relationships with internal and external collaborators Demonstrated ability to coach, mentor and/or cross train colleagues within core technical areas Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (e.g. investigations, procedures, change controls) and good Presentation skills. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
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Specialist Manufacturing
2 weeks ago
Dublin, Ireland Amgen SA Full timeThe Specialist in Manufacturing at Amgen provides technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards. Specialist - Manufacturing Provide...
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Specialist Manufacturing
2 weeks ago
Dublin, Ireland Amgen Full timeThe Specialist in Manufacturing at Amgen provides technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards. Specialist - Manufacturing Provide...
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Dublin, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for an Upstream Manufacturing Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 1 years of experience working in the pharmaceutical or...
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Dublin, Ireland Cpl Resources Full timeJO- Lean Manufacturing Specialist in Dublin 24 Cpl are working as the exclusive recruitment partner to support one of our legacy client partners to support them in sourcing and recruiting a Lean Six Sigma Manufacturing /Continuous Improvement or Process Excellence Specialist for their manufacturing site in Dublin 24 The company are a leading recognised...
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[Apply in 3 Minutes] Manufacturing Specialist
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South Dublin, Ireland Life Science Recruitment Full timeManufacturing Specialist - Investigation Lead RK3800 Manufacturing Specialist (Investigation Lead) 12 month contract Biopharmaceutical manufacturing Hybrid Description: The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be...
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Manufacturing Transformation Specialist New
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Dublin, Ireland CPL Full timeCpl in partnership with our client Pfizer are seeking a Manufacturing Transformation Specialist to join the team for an 11 month fixed term contract based at their state of the art site in Dublin, Grange Castle. This role has a hybrid working model attached. Background: An opportunity to be part of a new team whose aim is to provide process support,...
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Lean Manufacturing Specialist Dub 24 New
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Dublin, Ireland CPL Full timeLean Manufacturing Specialist in Dublin 24 Cpl are working as the exclusive recruitment partner to support one of our legacy client partners to support them in sourcing and recruiting a Lean Six Sigma Manufacturing / Continuous Improvement or Process Excellence Specialist for their manufacturing site in Dublin 24 The company are a leading recognised global...
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Dublin, Ireland Amgen Full timeAmgen Contract Development and Manufacturing Specialist About Amgen Amgen has been a Biotechnology Innovator since 1980, head quartered in Thousand Oaks in California. The Amgen site in Dn Laoghaire (ADL) has been open since 2011 and as such has continued to grow in the Amgen Network. At ADL we specialise in Formulation, Aseptic Drug Product Filling and...
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Dublin, Ireland Amgen Full timeAmgen Contract Development and Manufacturing Specialist About Amgen Amgen has been a Biotechnology Innovator since 1980, head quartered in Thousand Oaks in California. The Amgen site in Dn Laoghaire (ADL) has been open since 2011 and as such has continued to grow in the Amgen Network. At ADL we specialise in Formulation, Aseptic Drug Product Filling and...
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Manufacturing Support Specialist
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Dublin, Ireland PE Global Full timePE Global is currently recruiting for a Manufacturing Support Scientist on behalf of our client based in North Dublin: Full Time 6 Month Contract Responsibilities will include (but not limited to): Contributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product...
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Apply Now: Lean Manufacturing Specialist Dub 24
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Dublin, Ireland Cpl Resources Full timeJO- Lean Manufacturing Specialist in Dublin 24 Cpl are working as the exclusive recruitment partner to support one of our legacy client partners to support them in sourcing and recruiting a Lean Six Sigma Manufacturing /Continuous Improvement or Process Excellence Specialist for their manufacturing site in Dublin 24 The company are a leading recognised...
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(Only 24h Left) QA Manufacturing Specialist
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Dublin, Ireland Grifols, S.A Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Apply Now! Manufacturing Support Specialist
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Dublin, Ireland PE Global Full timePE Global is currently recruiting for a Manufacturing Support Scientist on behalf of our client based in North Dublin: Full Time 6 Month Contract Responsibilities will include (but not limited to): Contributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product...
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QA Specialist
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Dublin, Ireland PE Global Full timeThe Role: PE Global are recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire 12 Month initial contract - Hybrid Good technical writing for all deviation incidents, the team must write a thorough write up. So, the candidate must be comfortable with writing clear information and ensure it is detailed. Good project...
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Dublin, Ireland Cpl Healthcare Full timeCpl in partnership with SK pharmteco are hiring for a permanent QA Operations Specialist to join the team at the North Dublin site in Swords. ABOUT US? SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with revenues...
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Dublin, Ireland Tbwa ChiatDay Inc Full timeMid Market Account Executive, Manufacturing Industry Specialist Dublin Gong transforms revenue organizations by harnessing customer interactions to increase business efficiency, improve decision-making and accelerate revenue growth. The Revenue Intelligence Platform uses proprietary artificial intelligence technology to enable teams to capture, understand...
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QA Specialist
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Dublin, Ireland PE Global Full timeThe Role: PE Global are recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire 12 Month initial contract - Hybrid Good technical writing for all deviation incidents, the team must write a thorough write up. So, the candidate must be comfortable with writing clear information and ensure it is detailed. Good project...
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Specialist Scheduler
2 weeks ago
Dublin, Ireland Amgen Full timeSpecialist Scheduler Description The Specialist Scheduler is a key member of the Operations Planning Team working in the Supply Chain Organisation at Amgen Dun Laoghaire. The Planning team provides daily & weekly schedules/plans to the Vial & Syringe Filling Plants, Inspection Plant & Packing Plant plus plan the activities of the Maintenance Technical teams...
