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Validation Manager

Amgen · Dublin, Leinster, IE

Career Category Engineering Job Description Aseptic Processing Validation Manager The validation department performs sterilisation validation activities to e...

Job description

Career Category Engineering Job Description: 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 within the Aseptic Process Validation team. The Aseptic Process Sterilisation team perform validation/ re-qualification on critical GMP equipment such as critical HVAC systems -airflow visualisation and filter integrity testing activities, VPHP isolators, autoclaves, SIP systems, Lyophilisers as well as testing in response to changes to the production environment. The team also provide validation oversight on aseptic processing simulations (APS). Depending on experience, this role will manage a team responsible for the re-qualification team within some of these areas. 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. ·...