Process Validation Engineer
il y a 18 heures
Location: Ghent region, East Flanders, BelgiumContract Duration: Until 31 December 2026Working Hours: 40 hours per weekThe Opportunity:This role offers the chance to contribute to the launch of a newly built, advanced cell therapy manufacturing facility focused on CAR-T production for oncology indications. The site is being established to support the European supply of innovative autologous therapies that leverage a patient's own immune cells to target cancer.As part of an international collaboration, the manufacturing process is being transferred from an existing overseas facility to a new pilot and commercial production environment in Belgium. The programme is entering a critical scale-up and start-up phase, requiring strong validation and technology transfer expertise.Role & Responsibilities:As a member of the Manufacturing Excellence / MSAT function, you will play a key role in preparing the CAR-T production process for GMP manufacturing readiness. Your responsibilities will include:Defining validation strategies and developing, coordinating, and executing validation plansLeading and supporting activities related to sterilisation validation, hold time studies, APS/APQ and revalidation activitiesProviding subject-matter guidance on validation and qualification topics across cross-functional teamsAuthoring, reviewing, and approving validation plans, protocols, reports, and technical documentationSupporting technology transfer activities and the introduction of new equipment and systems into the manufacturing environmentParticipating in system implementation, process optimisation, and continuous improvement initiativesReviewing technical documentation to ensure alignment with current regulatory expectations, GMP standards, and industry best practicesRequirements for SuccessTo succeed in this role, you will bring solid GMP experience and a strong understanding of pharmaceutical or advanced therapy manufacturing environments.Essential qualifications and experience include:Bachelor's degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or a related disciplineIndustry experience within pharmaceuticals, biotechnology, cell or gene therapy, or plasma-derived productsHands-on experience with late-stage development, product introduction, or technology transfer into manufacturing sitesStrong understanding of manufacturing unit operations and validation lifecycle activitiesProject management capability with the ability to provide clear, timely updates on progress and risksAbility to collaborate effectively across technical, operational, and leadership levelsConfidence working in high-pressure environments with competing prioritiesIndependent working style combined with a collaborative, team-oriented mindsetFluency in both written and spoken Dutch and EnglishContract & Compensation:This is a long-term contract role running through to 31 December 2026 , offering a highly competitive hourly rate commensurate with experience and expertise.
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il y a 2 jours
Brussels, Belgique WhatJobs Temps pleinEngineer Process Support - Process Validation | Brussels Join to apply for the Engineer Process Support - Process Validation | Brussels role at Prothya Biosolutions Direct message the job poster from Prothya Biosolutions Overview Function: Engineer Process Support – Process Validation. Reports to the Supervisor of the Process Support team (PCS) in the...
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il y a 18 heures
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il y a 2 semaines
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il y a 4 jours
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