Process Validation Consultant
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Our client, a leading biotechnology organization, is seeking a specialist to support base business validation activities and strategic projects. This role involves designing and implementing process validation strategies to ensure cGMP readiness and process robustness within a cell and gene therapy environment.
- Participate in the design and implementation of Process Validation activities to support the strategic plan.
- Provide technical expertise in cell and gene therapy manufacturing to establish holistic Process Control Strategies.
- Draft and maintain manufacturing batch records, Validation Master Plans, and related technical documentation.
- Design and oversee validation studies including aseptic process simulation, PPQ, CCIT, and hold time studies.
- Conduct Process Risk Assessments and provide support for change controls, deviations, and CAPAs.
- Act as a Subject Matter Expert during internal and external regulatory audits such as FDA and EMA.
- Identify process improvement opportunities and contribute to data trend analysis and Statistical Quality Control.
- You have a Master's degree in a relevant scientific or engineering field.
- You bring 3+ years of experience in a cGMP environment within the biotech or biopharmaceutical industry.
- You have expertise in Process Validation including PPQ, CCIT, aseptic process simulation, and tech transfer.
- You possess knowledge of Risk Assessment methodologies and contamination control strategies.
- You bring experience with statistical analysis software such as JMP.
- You're proactive, analytical, and able to manage multiple priorities in a dynamic, matrixed environment.
- You are fluent in English and Dutch.
Nice to Haves
- Direct experience within cell and gene therapy manufacturing processes.
- Knowledge of French.
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