Process Validation Engineer (M/W/X) (Cell Therapy)

Location: Ghent, Belgium

Company

hirify.global is an independent technology consulting firm delivering solutions across Information System & Digital, Telecom, Life Sciences, and Engineering through an international team operating in more than 60 countries.

What you will do

• Support lead engineers with data gathering, drafting, and approval routing for annual Stage 3 continued process verification reports.
• Extract and structure manufacturing and analytical data from MES, LIMS, and SAP for CAR-T process metrics.
• Perform routine data entry and initial statistical analysis using JMP or Minitab to monitor critical process parameters and quality attributes.
• Identify process drift, out-of-trend data, and process variations for further investigation, coordinating with Quality Assurance and MSAT specialists on documentation and deviations.
• Map particle monitoring across the CAR-T manufacturing workflow, including sampling points, inspection methods, and data flows.
• Trend particulate data, investigate deviations and root causes, and present risk assessments and future-state governance proposals to the Particle Governance Board.

Requirements

• Experience in pharmaceuticals, biotechnology, cell therapy, human plasma-derived products, or a related industry.
• Experience introducing pharmaceutical products at manufacturing sites and supporting late-stage development, with knowledge of manufacturing-site unit operations.
• Strong working knowledge of current Good Manufacturing Practices (cGMP).
• Bachelor’s degree or higher in engineering, biotechnology, biomedical sciences, pharmacy, or a related field.
• Proficiency in project management, reporting, prioritization, independent work, problem-solving, and cross-functional collaboration.
• Fluent Dutch and English required.

Nice to have

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

Culture & Benefits

• Long-term projects averaging more than 18 months with major accounts and support from internal Centers of Excellence.
• Structured project check-ins, management support, and regular access to HR.
• Functional and geographic mobility opportunities across four areas of expertise and more than 60 countries.
• Access to training modules, in-house AI initiatives, and fully funded Microsoft certifications.
• Health insurance, remote work options, meal vouchers, a time savings account, and a referral bonus.

Hiring process

• Brief virtual or phone call.
• Approximately three interviews, varying by required seniority.
• Potential case study, technical assessment, role play, or problem-solving test.