Senior Validation Engineer at Haarlemmermeer, Noord-Holland

We are seeking a Senior Validation Engineer (40hrs/onsite) to join a major biopharmaceutical company engaged in the development of innovative cancer immunotherapy.

Must haves:

• Validation/qualification of (analytical) equipment, including both (writing) documentation and execution

• CSV principles, data integrity, and risk-based validation approaches

• Operating within a GMP / CAR T cell environment

• Effective communication, with a strong analytical mindset and attention to detail

Offer

•        Temporary agency contract for 12 months via Grafton (based on CLA ABU), with potential 6 months extension

•        Start date: ASAP

•        Salary: € 6.930,- gross per month based on 40 hours excl. 8% holiday allowance, 28 vacation days, paid public holidays, pension scheme via StiPP will switch with a total contribution of 23.4% (15.9% employer, 7.5% employee)

•        Opportunity to work an international fast-paced biopharmaceutical company curing cancer

Key Responsibilities

Validation & Qualification Execution

• Create, review, and approve qualification protocols (including vendor protocols), executed protocol summary reports, and Requirements Traceability Matrices (RTM) for equipment, utilities, facilities, and computerized systems.

• Develop, review, and approve Validation Project Plans and Validation Summary Reports.

• Plan, execute, review, and approve commissioning and qualification activities (IQ, OQ, PQ), including the investigation and resolution of deviations and exceptional conditions.

• Witness and oversee vendor commissioning and qualification activities as required.

• Support and maintain the periodic review program for validated systems.

• Perform and approve periodic evaluations to confirm the ongoing validated state of systems.

Project & Stakeholder Collaboration

• Actively participate in multidisciplinary teams as a CQV team member or CQV lead.

• Establish CQV strategies and approaches during planning, design, and execution phases.

• Collaborate closely with Manufacturing, Engineering, Quality, and external vendors to align validation activities.

• Support the introduction, qualification, and lifecycle management of new equipment and technologies used in CAR T manufacturing.

Risk, Change & Compliance Management

• Review and approve validation related deliverables such as System Impact Assessments, URS, FRS, configuration and design specifications, and risk assessments.

• Assess change controls for validation impact and define required qualification activities.

• Participate in deviation investigations, root cause analyses, and CAPA development and implementation.

Required Qualifications

Education

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline.

Experience

• Min 5 years of experience in commissioning, qualification, and validation within a GMP regulated environment. 10 years or more preferred.

• Demonstrated experience validating equipment, utilities, facilities, and computerized systems.

• Hands on experience executing IQ/OQ/PQ and managing validation documentation.

Technical & Regulatory Knowledge

• Strong knowledge of GMP and GxP requirements.

• Familiarity with regulatory expectations from authorities such as FDA and EMA.

• Experience applying risk based validation and quality risk management principles.

Interested?

Please do reach out to Marcella Henryati, Recruitment Consultant

Phone: 06-58811958 / E-mail: marcella.henryati@grafton.com