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Technics
Operations Expert - Pharma
Description de fonction
Are you ready to make a difference? As an Operations Expert at our client, you will be part of the team responsible for producing products in a cGMP cleanroom. You will oversee various units within process operations, including component preparation, manufacturing support, fill & finish, and cryopreservation, ensuring compliance with cGMP standards.
Working in a cross-functional environment, you will complete production tasks, drive continuous improvement, and collaborate with departments such as Planning, QC, Maintenance, and Quality. Located in the GMP Facility in Ghent, you will report to the Operational Manager, Europe, and act as the first point of contact for junior operators on the production floor.
As an Operations Expert, you will:
Oversee daily CAR-T production in a sterile cGMP environment to support clinical and commercial readiness, ensuring compliance with safety, quality, and cGMP requirements.
Act as an Operational Ambassador by:
- Supporting the creation of GMP documentation for timely production execution.
- Executing aseptic manual processes for clinical and commercial grade ATMPs, including cell isolation, selection, activation, transduction, culture, fill & finish, and cryopreservation, while maintaining Good Documentation Practices (GDP).
- Working in a cleanroom environment (Grade A/B/C/D) to guide and perform production tasks, ensuring adherence to safety policies and quality systems.
- Managing daily production planning and routine production flow.
- Supporting manufacturing investigations and creating/revising operational procedures, including work instructions and batch records.
- Building strong partnerships with Planning, Manufacturing & Process Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse, and Quality.
- Acting as a Production Expert by training and coaching junior technicians, troubleshooting daily operational issues, and ensuring adherence to SOPs and safety practices.
Profil
Are you the Operations Expert we are looking for?
* You have a master's or PhD degree in bioengineering, biotechnology or pharmacy - or equivalent experience.
* Some operational experience within a GMP or ATMP environment in the biotech/ biopharmaceutical industry is a plus.
* Previous experience in manufacturing, quality or engineering is required.
* Strong influence and relationship building skills with an emphasis on teamwork
* Strongly developed organizational skills
* You are able to manage changing priorities and meet critical deadlines
* You are analytically strong, problem-solving, programmatic and positively critical in your thinking
* You have a flexible mindset and a CAN DO attitude
* Experience with MS Office; being able to work with SAP & GMP systems is definitely a plus!
* You can communicate fluently in English. Knowledge of Dutch is a plus.
Offre
As an Operations Expert:
- You will join an exciting pharmaceutical company with opportunities for growth.
- You will work within a strong,respectful and diverse team where everyone is welcome.
- You will receive an attractive salary package including meal vouchers and eco vouchers.
- Hospitalization insurance, group insurance and a bonus complete the salary package.
- You work in a 2-shift system (6h - 16h / 14h - 00h) in a regime in which you work 4 days and have 4 days off, etc. ensuring a good balance between work and private life. Temporarily it is possible that you also have to work from 8h - 18h, 10h - 20h, 12h - 22h. You are therefore able to work in all 5 possible regimes.
- You will work in an environment where loyalty and team spirit are highly valued.
Information
Our client, based in Zwijnaarde, is a global biotechnology company bringing the innovative cell therapy to Ghent. With this, the team makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases. They are currently in a phase of strong growth and are looking for motivated and dedicated team members.