Manager Validation Engineering

Progressive; Amsterdam; On-site; EUR 55,000 - 75,000; Full time

Job summary

A leading engineering firm is seeking an experienced Validation Engineer in Amsterdam, Netherlands, to oversee qualification and validation activities in a GMP-regulated environment. Responsibilities include creating qualification protocols, executing validation projects, and collaborating with various departments to ensure regulatory compliance. Candidates should have at least 5 years of relevant experience and hold a relevant degree. Opportunities for contract extension may arise, and a commitment of 40 hours per week is expected.

Qualifications

• Minimum of 5 years in commissioning, qualification, and validation in a GMP environment.
• Experience validating equipment, utilities, and computer systems.
• Familiar with regulatory expectations from FDA and EMA.

Responsibilities

• Create, review, and approve qualification protocols and reports.
• Plan and execute qualification activities (IQ, OQ, PQ).
• Collaborate with Manufacturing and Engineering on validation processes.

Skills

Commissioning and qualification

GMP knowledge

Analytical skills

People management

Risk-based validation

Education

Bachelor's or Master's in Engineering, Life Sciences

Job description

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 [e-mail]