In this role, you will oversee and execute commissioning and qualification activities for various systems within a project. You will ensure compliance with GMP standards, support vendor testing, and collaborate across teams to deliver quality results. Your expertise will help maintain operational readiness and regulatory compliance.
Start Date: ASAP
Duration: 6 Months (extension 6-12 Months possible)
Place of Work: Stein (AG)
Key Responsibilities
Develop and approve system boundaries
Prepare, execute, and approve Design Qualification documentation, including IQ release
Conduct GMP-related Risk Assessments
Lead commissioning activities, supervise vendors during testing, and ensure quality standards
Prepare, execute, and approve Installation Qualification, releasing for OQ
Facilitate Operational Qualification, releasing for operational use
Support Design Qualification efforts for impact-critical systems
Assist in implementing the Installation Commissioning process following project protocols
Support additional C&Q tasks as needed
Proactively address and resolve issues
Manage interface coordination between systems and teams
Perform shift work when required
Candidate Profile
Bachelor's degree in Life Sciences or Engineering
Over 3 years of experience in commissioning and qualification processes
Hands-on experience with DeltaV (Emerson) and other control systems
Proficiency with COMOS/KNEAT platforms
Excellent written and spoken English skills
Solid understanding of cGMP standards and regulatory requirements
Ability to work independently and meet deadlines
Preferred Qualifications
Familiarity with commissioning and qualification approaches specific to biopharmaceuticals
Industry-specific knowledge in biopharmaceutical manufacturing
Job ID 41181044
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