Validation Manager
6 hours ago
Aseptic Processing Validation Manager The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Manager for the HVAC /AVS (Airflow Visualisation)/APS (Aseptic Process Simulation/media fill) Validation team within the Aseptic Process Validation team. The Aseptic Process Sterilisation team perform /validation/ re-qualification on equipment such as VHP isolators, autoclaves, CIP/SIP systems and Lyophilisers and provide validation oversight on aseptic processing simulations. This role will focus on managing the team responsible for HVAC requalification in the production environments, including managing the routine re-qualification program of airflow visualisation and filter integrity testing activities as well as testing in response to changes to the production environment. The activities of the Aseptic Processing Validation Manager are to: Provide leadership and guidance to the validation team, with clear goals and expectations for the day-to-day activities for Validation, Re-Qualification and Periodic Review programs. Support Operations from a Validation perspective to deliver and maintain equipment in a qualified state in the most efficient manner possible. Ensure Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation network. Develop and ensure internal policies, procedures and practices associated with maintenance of the Site Validation Master Plan and Requalification Plans specific to area of responsibility. Responsible for managing and co-ordinating the aseptic process simulation program, including aseptic intervention review, protocol and summary report review, MES hold time support. Responsible for supporting for airflow visualisation studies and HVAC requalification program. Collate and report on relevant validation data and metrics. Provide validation support for Amgen's quality management system, including change control, deviation and CAPA processes. Participate and deliver regulatory filings and RTQ's for validation. Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process. Work on moderately complex to complex problems, where analysis of situations or data requires in-depth evaluation of various factors. Strong judgment is required in resolving problems and making recommendations. Writes and/or implements, owns and approves changes to controlled documents (e.g., SOPs, Specifications, Master Protocols, etc.) as needed. Support senior leadership in creating and implementing mid to long- term plans for department. Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels. Manage competing priorities within the team and create an effective team environment. Coordinate contract personnel through completion of assignments. Raising of PO's, negotiating with vendors and interviewing candidates. Manage FTE validation personnel, including organizing and prioritizing department goals & objectives, performing training, writing performance reviews, resolving people management issues for direct reports. Responsible for staff development, managing high performing teams, budgeting and cost control, talent mapping, succession planning, the development of strong leaders within the function. Ensure projects and routine work are executed safely, efficiently, and in accordance with all applicable codes and Amgen Standards. Provide department leadership and present validation packages for internal and external compliance audits as required and interfaces with regulatory agencies for the equipment validation team. Review and approves protocols, reports and data tables generated by staff and contract personnel. Basic Qualifications: Master's degree with 5+ years of experience in validation, engineering or BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality. Preferred Qualifications: In-depth understanding and application of validation principles, concepts, practices, and standards. In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing Extensive working knowledge of sterilisation/decontamination systems and industry practices. Experience working with critical HVAC systems and qualification of AVS Experience with APS Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution Strong program and change management skills Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives. Able to adjust workload based upon changing priorities Previous people management experience highly desired. Able to express ideas and present information effectively to Amgen leadership, within team functions, and with external partners Ability to think critically with demonstrated troubleshooting and analytical 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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Validation Manager
6 days ago
Dublin, Ireland Amgen SA Full timeAseptic Processing Validation Manager The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Manager for the HVAC /AVS (Airflow...
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Apply Now: Validation Manager
3 days ago
Dublin, Ireland Amgen Full timeAseptic Processing Validation Manager The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Manager for the HVAC /AVS (Airflow...
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Validation Engineer
24 hours ago
Dublin, Ireland Morgan McKinley Full timeAbout the Job: An exciting opportunity has arisen for a Validation Engineer to join my client's dynamic validation team. This role focuses on managing the validation of computerized systems, specifically in the medical device industry. Key responsibilities include developing and reviewing validation documentation in alignment with industry standards and...
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Manager, Scientific Affairs
2 weeks ago
Dublin, Ireland ENGINEERINGUK Full timeManager, Scientific Affairs - Test Validation Manager, Scientific Affairs ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. This is an exciting...
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Senior Validation Engineer
2 weeks ago
Dublin, Ireland Embecta Full timeembecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and...
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Senior Validation Engineer
3 days ago
Dublin, Ireland Embecta Full timeembecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and...
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Validation Engineer
3 weeks ago
Dublin, Ireland Claran Consultants Ltd Full timeThis is what you will do: The Thermal Systems Validation Engineer will prepare the necessary documentation and monitor progress for technical projects and validated status of the Thermal Systems equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms and CTUs) across the organization. The incumbent will be a contributor and Subject...
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Validation Engineer
4 days ago
Dublin, Ireland Claran Consultants Ltd Full timeThis is what you will do: The Thermal Systems Validation Engineer will prepare the necessary documentation and monitor progress for technical projects and validated status of the Thermal Systems equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms and CTUs) across the organization. The incumbent will be a contributor and Subject...
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Validation Engineer
6 hours ago
Dublin, Ireland Claran Consultants Ltd Full timeThis is what you will do: The Thermal Systems Validation Engineer will prepare the necessary documentation and monitor progress for technical projects and validated status of the Thermal Systems equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms and CTUs) across the organization. The incumbent will be a contributor and Subject...
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QA System and Validation
2 weeks ago
Dublin, Ireland CPL Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: • Assessment of changes for GMP compliance in accordance with site change control procedure for...
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QA System and Validation Specialist
2 weeks ago
Dublin, Ireland Cpl Resources Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...
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Senior QA Validation Specialist
3 days ago
Dublin, Ireland PE Global Full timeDescription: PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 18-month contract role. Overview: We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new...
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Senior Validation Professional- Medical Device
2 weeks ago
Dublin, Ireland Brightwater Full timeSenior Validation Professional-Medical Device About the Company My client is a leading multinational medical device company, specialising in innovative solutions that improve quality of life. About the Position This is an exciting opportunity to manage the validation lifecycle and Advanced Product Quality Planning (APQP) processes for this busy medical...
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Senior Validation Professional- Medical Device
6 hours ago
Dublin, Ireland Brightwater Full timeSenior Validation Professional-Medical Device About the Company My client is a leading multinational medical device company, specialising in innovative solutions that improve quality of life. About the Position This is an exciting opportunity to manage the validation lifecycle and Advanced Product Quality Planning (APQP) processes for this busy medical...
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Validation Analyst I
6 hours ago
Dublin, Ireland ICON Clinical Research Limited Full timeValidation Analyst I (Labs) - Dublin, Ireland - Office-based ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Job Description: Recognize, exemplify...
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▷ High Salary! Validation Engineer New
2 weeks ago
Dublin, Ireland CPL Full timeOn behalf of our client, a global medical devices company, we are currently recruiting for a Validation Engineer. This is a permanent, full-site position site based in North Wicklow/South Dublin. Reports to Maintenance, Engineering and Validation Manager Essential responsibilities - Compilation and execution of validation protocols - Compilation of...
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Cleaning Validation Specialist
7 days ago
Dublin, Ireland Cpl Healthcare Full timeCLEANING VALIDATION SPECIALIST Cpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term contingent contract at their state of the art plant in Dublin Grange Castle. Job Purpose: Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team...
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Cleaning Validation Specialist
2 weeks ago
Dublin, Ireland CPL Full timeCLEANING VALIDATION SPECIALIST Cpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term contingent contract at their state of the art plant in Dublin Grange Castle. Job Purpose: Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team...
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[3 Days Left] Cleaning Validation Specialist
2 weeks ago
Dublin, Ireland Life Science Recruitment Full timeWe’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties 1. Execute cleaning cycle development and PQ of equipment. 2. Writing and adhering to validation strategies,...
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Senior QA Validation Specialist
1 week ago
Dublin, Ireland PE Global Full timeDescription: PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 18-month contract role. Overview: We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new...
