Operations Technician

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. Functieomschrijving Are you ready to make a difference? As an Operations Technician 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, while 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. Profiel

• As an Operations Technician, you have obtained a master's degree in Science, Bio-Engineering, BioTechnology, Pharmacy, or related field, or equivalent experience.
• Knowledge of GMP regulations & EMEA- guidance is preferred but not mandatory.
• 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 Van € 3.265 tot € 3.600 per maand Join the team as an Operations Technician 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 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.

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