La description
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.
Jobomschrijving
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.
Jobgerelateerde competenties
Persoonsgebonden competenties
Ons aanbod
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.
Contract
- Dagwerk.
- Voltijds
- Onbepaalde duur
- Gewoon contract.