Lead Validation Engineer, Hoofddorp, Noord-Holland

The Company
A global biopharmaceutical organization operating in a highly regulated GMP environment, focused on advanced therapies and innovative manufacturing technologies. The company supports complex production processes with strong quality and compliance standards across international operations.

About the Role
This role is responsible for leading and executing commissioning, qualification, and validation activities for equipment, utilities, facilities, and computerized systems. The position plays a key role in ensuring systems remain compliant throughout their lifecycle while supporting the introduction of new technologies in a fast paced manufacturing environment.

Responsibilities
- Create, review, and approve qualification protocols, executed protocol summary reports, and requirements traceability matrices
- Develop and approve validation project plans and validation summary reports
- Plan, execute, and oversee IQ OQ and PQ activities, including deviation investigations and resolution
- Witness and support vendor commissioning and qualification activities
- Maintain and support periodic review programs for validated systems
- Perform periodic evaluations to ensure systems remain in a validated state
- Act as a CQV team member or CQV lead within multidisciplinary project teams
- Define CQV strategies during planning, design, and execution phases
- Collaborate with Manufacturing, Engineering, Quality, and external vendors
- Review and approve system impact assessments, URS, FRS, design specifications, and risk assessments
- Assess change controls for validation impact and define required qualification activities
- Support deviation investigations, root cause analysis, and CAPA implementation

Requirements
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline
- Minimum of 5 years experience in commissioning, qualification, and validation within a GMP environment
- Extensive hands on experience executing IQ OQ and PQ
- Experience validating equipment, utilities, facilities, and computerized systems
- Strong knowledge of GMP and GxP requirements
- Familiarity with FDA and EMA regulatory expectations
- Experience applying risk based validation and quality risk management principles

Other Information
- Collaboration with internal stakeholders and external vendors
- High level of accuracy and documentation discipline

 

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