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