Process Validation Consultant

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.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.