Process Validation Engineer Cell Therapy

• Support the generation of annual stage 3 continued process verification reports by gathering data and drafting technical sections.
• Extract and structure manufacturing and analytical data from electronic systems including MES, LIMS, and SAP.
• Perform statistical trending and initial analysis of critical process parameters and quality attributes using JMP or Minitab.
• Monitor and baseline particle monitoring workflows to identify process drifts and investigate root causes of deviations.
• Design future-state governance frameworks to improve monitoring strategies and optimize handling protocols.
• Lead technical boards by presenting data reports, risk assessments, and proposed strategic frameworks to cross-functional stakeholders.

• You have a Bachelor’s degree or higher in engineering, biotechnology, biomedical sciences, or pharmacy.
• You bring 5+ years of experience in the pharmaceutical or biotechnology industry, specifically regarding product introduction or late-stage development.
• You possess strong technical knowledge of cGMP and manufacturing site unit operations.
• You have experience with statistical analysis tools such as JMP or Minitab and data systems like MES, LIMS, or SAP.
• You're able to manage projects independently, handle conflicting interests, and communicate effectively across different levels of an organization.
• You are fluent in Dutch and English.

Nice to Haves

• Experience working in a controlled cleanroom environment under aseptic conditions.

• 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.