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Sterilization Systems Expert

1 week ago


Copenhagen, Copenhagen, Denmark AM Group Full time
About the Role

This is a mid-senior level position responsible for leading SIP projects from conception to completion. The successful candidate will have expertise in clean steam sterilization processes and equipment, as well as experience working in process engineering.

Responsibilities:
  1. Project Management: Manage projects involving SIP systems, ensuring timely delivery and adherence to GMP standards.
  2. Validation Activities: Perform validation tasks, including FAT, SAT, IQ, OQ, and PQ, using hands-on approach.
  3. Documentation: Draft and review validation protocols, reports, and approval documentation.
  4. Equipment Integration: Oversee the integration and validation of clean steam equipment in compliance with cGMP requirements.
  5. Collaboration: Collaborate with cross-functional teams to ensure seamless project execution.

The successful candidate will have a strong technical background and practical experience in validation.