Senior Validation Engineer, Hoofddorp, Noord-Holland

The Company
A science driven biopharmaceutical organization operating in a highly regulated manufacturing environment. The company focuses on advanced therapies and innovative technologies while maintaining strong quality and compliance standards.

Role Description
The Senior Validation Engineer is responsible for leading commissioning, qualification, and validation activities across equipment, utilities, facilities, and computerized systems. This role ensures systems meet GMP and regulatory requirements throughout their lifecycle. The position works closely with cross functional teams and external vendors in a fast paced manufacturing environment.

Responsibilities
- Create, review, and approve qualification protocols, executed protocol summary reports, and Requirements Traceability Matrices for equipment, utilities, facilities, and computerized systems
- Develop, review, and approve Validation Project Plans and Validation Summary Reports
- Plan, execute, review, and approve IQ, OQ, and PQ activities including deviation investigation and resolution
- Witness and oversee vendor commissioning and qualification activities
- Support and maintain the periodic review program for validated systems
- Perform periodic evaluations to confirm systems remain in a validated state
- Participate as a CQV team member or CQV lead in multidisciplinary project teams
- Define CQV strategies during planning, design, and execution phases
- Collaborate with Manufacturing, Engineering, Quality, and external vendors
- Support qualification and lifecycle management of new equipment and technologies used in CAR T manufacturing
- Review and approve validation deliverables such as impact assessments, URS, FRS, design specifications, and risk assessments
- Assess change controls for validation impact and define required qualification activities
- Participate in deviation investigations, root cause analysis, and CAPA implementation

Requirements
- Bachelors or Masters degree in Engineering, Life Sciences, or a related technical discipline
- Minimum five years of experience in commissioning, qualification, and validation within a GMP regulated environment
- Ten or more years of experience preferred
- Demonstrated experience validating equipment, utilities, facilities, and computerized systems
- Hands on experience executing IQ, OQ, and PQ
- Strong knowledge of GMP and GxP requirements
- Familiarity with FDA and EMA regulatory expectations
- Experience applying risk based validation and quality risk management principles
- Experience working with external vendors and contractors
- High attention to detail and strong documentation discipline

Other Information
- On site collaboration with cross functional teams
- Involvement in advanced therapy manufacturing programs

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