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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