Process Validation Engineer Cell Therapy

Pauwels Consulting; Oost-Vlaanderen; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking an experienced professional to support late-stage development and process verification in a pharmaceutical/biotech setting. You will extract data from MES, LIMS, and SAP, perform statistical analyses with JMP or Minitab, and draft technical sections for annual reports.

You will drive governance improvements, monitor process parameters, and present findings to cross-functional teams. Dutch and English fluency are required.

Qualifications

• Bachelor’s degree or higher in engineering, biotechnology, biomedical sciences, or pharmacy.
• 5+ years of experience in the pharmaceutical or biotechnology industry, specifically product introduction or late-stage development.
• Strong knowledge of cGMP and manufacturing site unit operations.
• Experience with JMP or Minitab and data systems MES, LIMS, or SAP.
• Able to manage projects independently and communicate across organizational levels.

Responsabilités

• 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 MES, LIMS, and SAP.
• Perform statistical trending and initial analysis using JMP or Minitab.
• Monitor and baseline particle monitoring workflows to identify process drifts and root causes of deviations.
• Design future-state governance frameworks to improve monitoring strategies and handling protocols.
• Lead technical boards by presenting data reports, risk assessments, and proposed strategic frameworks to cross-functional stakeholders.

Connaissances

JMP

Minitab

cGMP

Dutch

English

data analysis

project management

statistical analysis

Formation

Bachelor’s degree or higher in engineering, biotechnology, biomedical sciences, or pharmacy

Outils

MES

LIMS

SAP

Description du poste

• 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.