Process Validation Engineer Cell Therapy
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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
#ProcessValidation #CellTherapy #CART #BiotechJobs #PharmaEngineering #GhentJobs #GMP #LifeSciences
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