Validation Engineer

Our client, a leading organization in the pharmaceutical and biotechnology sector, is seeking a Validation Engineer to support the validation of equipment, systems, and processes. This role ensures that facilities, utilities, and computerized systems remain compliant with regulatory and quality requirements throughout their entire lifecycle.

• Develop, execute, and review validation documentation including URS, IQ, OQ, PQ, and PV for various systems.
• Support commissioning and qualification (C&Q) activities for new or modified equipment, systems, and facilities.
• Draft and maintain validation master plans, protocols, and traceability matrices to ensure compliance.
• Coordinate with Engineering, QA, and Manufacturing teams to align validation activities with project timelines.
• Investigate deviations and non-conformances during validation execution and support root cause analysis and CAPA follow-up.
• Assess the validation impact of proposed changes through the standard change control process.
• Maintain systems in a validated state by performing periodic reviews and re-validation as required.

• You have a Bachelor's or Master's degree in engineering, life sciences, pharmacy, or a related technical field.
• You bring 1+ years of relevant experience in the pharmaceutical or biotechnology manufacturing industry.
• You possess working knowledge of cGMP and regulatory frameworks such as FDA and EU GMP.
• You have experience with validation methodologies including IQ, OQ, PQ, and process validation.
• You bring knowledge of CSV and GAMP5 standards for computerized systems.
• You're a proactive team player with strong problem-solving skills and an ownership-driven attitude.
• You are fluent in Dutch and English.

Nice to Haves

• Knowledge of ICH Q7-Q12 guidelines.
• Experience with cleaning validation protocols.

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