Process Validation Engineer – Cell Therapy (Ghent)

Randstad Belgium; Oost-Vlaanderen; On-site; EUR 52,000 - 72,000; Full time

Job summary

Randstad Belgium is seeking a Process Validation Engineer in Ghent, Belgium, to lead critical validation activities and contribute to the expansion of an advanced cell therapy program. You will work on PPQ, APS, smoke studies, and hold-time validation within a manufacturing excellence team, ensuring GMP compliance and successful scale-up.

Ideal candidates have a bioengineering/biotech/pharmacy background, hands-on cGMP experience, and fluency in Dutch and English, with strong ownership and

Qualifications

• Bachelor's or Master's in Bioengineering, Biotechnology, Biomedical Sciences, or Pharmacy.
• Proven experience in Pharma/Biotech/Cell Therapy or biologics manufacturing and tech transfer.
• Solid cGMP knowledge; aseptic or cleanroom operations experience is a strong asset.
• Fluent in Dutch and English.

Responsibilities

• Define, plan, and lead validation activities (PPQ, APS, smoke studies, hold-time validation).
• Drive sterilization validation and equipment/system introductions.
• Contribute to technology transfer and late-stage process optimization.
• Draft, review, and approve validation plans, protocols, and regulatory reports.

Skills

Dutch language proficiency

English language proficiency

cGMP knowledge

Project management

Tech transfer experience

Education

Bachelor's or Master's in Bioengineering/Biotech/Biomedical Sciences/Pharmacy

Job description

Randstad Belgium is seeking a Process Validation Engineer in Ghent, Belgium, to lead critical validation activities and contribute to the expansion of an advanced cell therapy program. You will work on PPQ, APS, smoke studies, and hold-time validation within a manufacturing excellence team, ensuring GMP compliance and successful scale-up.

Ideal candidates have a bioengineering/biotech/pharmacy background, hands-on cGMP experience, and fluency in Dutch and English, with strong ownership and