Pharma

Pharma

Operations Technician - Pharma

9052 ZWIJNAARDE
Vast contract
Master
35 u/week
3.265 - 3.600 €/maand
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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

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.

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.

Heb je interesse in deze vacature?

Solliciteer nu en we nemen spoedig contact met je op.
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Vragen?

Heb je een vraag naar aanleiding van deze vacature? Aarzel niet en neem contact met ons op.

Start People Gent GT
+32 (0)9 269 37 20
gent@startpeople.be
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