Process Validation Engineer Cell Therapy

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

Ready to shape the future of Cell Therapy? | Process Validation Engineer (Ghent)

Advanced therapies are redefining how we fight cancer. By harnessing the power of a patient's own immune system, CAR-T technology offers real hope where conventional treatments fall short.

To support the expansion of this life-changing therapy across Europe, a leading biopharmaceutical player is launching a brand-new, state-of-the-art production site in Ghent.

We are currently looking for a Process Validation Engineer to play a pivotal role in the Manufacturing Excellence team during this greenfield and pilot plant scale-up.

What you will be doing:

• Define, plan, and lead key validation activities (PPQ, APS, smoke studies, hold-time validation).
• Drive sterilization validation and equipment or system introductions.
• Play an active part in technology transfer and late-stage process optimization.
• Draft, review, and approve critical validation plans, protocols, and regulatory reports.

What we are looking for:

• Education: Bachelor's or Master's in Bioengineering, Biotechnology, Biomedical Sciences, or Pharmacy.
• Experience: Proven background in Pharma, Biotech, Cell Therapy, or biologics manufacturing and tech transfer.
• Expertise: Solid cGMP knowledge; aseptic or cleanroom operations experience is a strong asset.
• Languages: Fluent in both Dutch and English (mandatory).
• Mindset: Strong project ownership, problem-solving drive, and team spirit in a fast-paced environment.

Location: Ghent, Belgium

Contract: Full-time

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