Cleaning Validation Engineer
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Prepare and maintain cleaning validation documentation including protocols, reports, and risk assessments.
Coordinate validation activities and physical testing such as swabbing and sampling in collaboration with the laboratory.
Manage the introduction of new products and equipment into the validation program through the change control system.
Investigate deviations and technical data failures while proposing effective corrective actions.
Support internal and external audits by providing technical expertise and troubleshooting.
Contribute to periodic review processes to ensure ongoing compliance with quality standards.
You have a Master's degree in (Bio)Sciences, Life Sciences, Pharmaceutical Sciences, or (Bio/Industrial) Engineering.
You bring 3+ years of experience in validation, quality, or project engineering within a GMP production environment.
You possess knowledge of cleaning technologies and methodologies such as CIP/COP and Cleaning Validation.
You have a solid understanding of regulatory frameworks including Eudralex, ICH, 21 CFR, ISO 14644, and EU Annex 1.
You're proactive with strong project management, analytical, and communication skills.
You are fluent in Dutch and English.
Nice to HavesFamiliarity with systems such as eLIMS, SAP, PASx, Minitab, or Emerson Delta V.
Knowledge of EU/US Pharmacopoeia.
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