Manager Validation Engineering

Details

Working hours:

40 hours per week
Contract duration: until 31 December 2026 (likely chance of extension)
Responsibilities   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
Requirements   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
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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