- Works daily in a cleanroom manufacturing environment (Grade A/B/C/D)
- Manufactures clinical & commercial grade ATMPs by aseptic manual process, including isolation, selection, activation, transduction, culture, fill and finish and cryopreservation of cells according to SOPs and aseptic techniques
- Performs in process control testing on batch samples, such as cell counting and viability
- Keeps equipment operating by following operating instructions, troubleshooting breakdowns and calling for repairs
- Contributes to activities related to processes optimizations, and introduction of new products, procedures and equipment in GMP areas
- Participates in the follow-up of QMS-related tasks, including Change Control Request (CCR), deviations/events and CAPA
- Provides support to writing and revising SOPs and associated documents (incl. batch records, work files, checklists, procedures) related to routine Production documentation.
- Manages raw materials, consumables and wastes, incl. preparation of internal orders, entry and exit from the zones, cleaning and storage, according to SOPs
- Works in a constructive and flexible way in a team
- Graduate, Bachelor's, Master's degree in Science, Bio-Engineering, BioTechnology, Pharmacy or related field or equivalent experience required
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Strong influence and relationship building skills with an emphasis on teamwork
- In-depth understanding of function and application of product
- Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
- Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell based products.
- Focus on quality, compliance and detail
- Ability to work in (transversal) teams - Team spirit
- Strong problem solving, pragmatic and positive critical thinking skills
- Can do attitude, Right first time
- Self-motivated, enthusiastic personality, team player with a desire to learn new skills
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
- Proficient user of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
- Experience working in cGMP systems including PASx, eLIMs, Siemens, and SAP is preferred
- Ability to accommodate unplanned overtime on little to no prior notice
- Ability to accommodate changes in the schedule including working in other shifts, evenings and weekends as per operational needs is required.
- Fluent in English, knowledge of Dutch is a plus.
- You are part of a fast-growing international company.
- You will have the opportunity to participate in research with the ultimate goal of curing life-threatening diseases.
- Attractive salary package with various fringe benefits.
- Very modern, multicultural and highly technological working environment.
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Lab Technician- Biotechnology-Gent - Ghent, België - Page Personnel
Beschrijving
These are the responsibilities of a Laboratory Technician:
This is the profile of a Laboratory Technician:
This is the offer for a Laboratory Technician:
