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Aseptic Process Validation Manager

2 weeks ago

Dublin, Dublin City, Ireland Amgen SA Full time
Job Description

The Aseptic Process Sterilization team performs validation/re-qualification on equipment such as VHP isolators, autoclaves, CIP/SIP systems, and Lyophilizers. This role will focus on managing the routine re-qualification program of airflow visualization and filter integrity testing activities.

  • Provide leadership and guidance to the validation team, with clear goals and expectations for day-to-day activities.
  • Support Operations from a validation perspective to deliver and maintain equipment in a qualified state.
  • Develop and ensure internal policies, procedures, and practices associated with maintenance of the Site Validation Master Plan.