Process Validation Engineer Cell Therapy

Il y a 3 jours

OostVlaanderen, Oost-Vlaanderen, Belgique Pauwels Consulting Temps plein 65 000 € - 90 000 € Contrat

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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.