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Pharma
Operations Technician / Operations Expert - Pharma
Functieomschrijving
Are you ready to make a difference? As an Operations Technician or an Operations Expert at our client, you will be at the forefront of revolutionizing cell therapy processes. Your role will involve conducting operations, including cell culture, purification, aseptic processing, fill & finish, and cryopreservation, ensuring compliance with safety policies, quality systems, and cGMP requirements.
Key Responsibilities:
Cleanroom Manufacturing: Operate daily in a Grade A/B/C/D cleanroom environment, maintaining equipment and facility cleanliness.
Aseptic Processing: Manufacture clinical and commercial-grade ATMPs through aseptic manual processes, including cell isolation, selection, activation, transduction, culture, fill and finish, and cryopreservation.
Quality Control: Perform in-process control testing on batch samples, ensuring high standards of cell counting and viability.
Equipment Maintenance: Keep equipment running smoothly by following instructions, troubleshooting issues, and coordinating repairs.
Process Optimization: Contribute to process optimization, introduce new products, procedures and equipment in GMP areas.
Documentation: Support writing and revising SOPs and other production-related documents, manage raw materials, consumables and waste.
Continuous Improvement: Participate in QMS-related tasks, including Change Control Requests, deviations, and CAPA.
As an Operations Expert you're responsible for training and coaching junior technicians, troubleshooting daily operational issues, and ensuring adherence to SOPs and safety practices.
Profiel
- As an Operations Technician, you have obtained a master's degree in Science, Bio-Engineering, BioTechnology, Pharmacy, or related field, or equivalent experience. As an Operations Expert, you have obtained a PhD degree in a relevant field or a master's degree with a minimum of 3 years of relevant working experience.
- Knowledge of GMP regulations & EMEA- guidance is preferred.
- Strong interpersonal skills with a focus on teamwork.
- Clear verbal and written communication skills with attention to detail.
- Familiarity with cGMP regulations and ATMP (Advanced Therapy Medicinal Products) guidance for cell-based product manufacturing.
- Strong problem-solving abilities with a positive attitude.
- Self-motivated with a desire to learn and teach others.
- Proficiency in Microsoft Office applications.
- Experience with cGMP systems like PASx, eLIMs, Siemens, and SAP is preferred.
Aanbod
Join the team as an Operations Technician or an Operations Expert and play a crucial role in a cleanroom environment.
- 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 will 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.
Bedrijfsinfo
Our client, based in Zwijnaarde, is a global biotechnology company that brings innovative cell therapy to Ghent.
The team makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases.
The company is currently in a phase of strong growth and is looking for motivated and dedicated team members.