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- Working hours: 40 hours per week
- Contract duration: until 31 December 2026 (likely chance of extension)
- Creating, reviewing, and approving qualification protocols, executed protocol summary reports, and Requirements Traceability Matrices for equipment, utilities, facilities, and computerized systems
- Developing, reviewing, and approving Validation Project Plans and Validation Summary Reports
- Planning, executing, reviewing, and approving commissioning and qualification activities (IQ, OQ, PQ), including deviation investigation and resolution
- Witnessing and overseeing vendor commissioning and qualification activities
- Supporting and maintaining periodic review programs to ensure systems remain in a validated state
- Collaborating with Manufacturing, Engineering, Quality, and external vendors
- Defining CQV strategies during planning, design, and execution phases
- Reviewing change controls for validation impact and defining required qualification activities
- Participating in deviation investigations, root cause analyses, and CAPA implementation
- Bachelor\'s or Master\'s degree in Engineering, Life Sciences, or a related technical discipline
- Minimum of 5 years of experience in commissioning, qualification, and validation within a GMP‑regulated environment
- Experience validating equipment, utilities, facilities, and computerized systems xgiwjmb
- Strong knowledge of GMP and GxP requirements
- Familiarity with regulatory expectations from authorities such as the FDA and EMA
- Experience with risk‑based validation and quality risk management
- Strong analytical skills and attention to detail
- Experience in people management and working with external vendors
If you are interested or know someone who might be suitable, please apply via here or get in touch via e-mail with
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