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    Laboratory Technician - Courcelles, België - Page Personnel

    Page Personnel
    Page Personnel Courcelles, België

    1 dag geleden

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    Beschrijving

    These are the responsibilities of a Laboratory Technician:

    * Works daily in a cleanroom manufacturing environment (Grade A/B/C/D)
    * Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas, mainly in grade 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
    * As part of the development program, the CAR-T technician can get the proper training and qualification to prepare sterile culture media and solutions according to SOPs and aseptic techniques
    * Completes diligently all GMP documentation (forms, reports, logs, and records of equipment and batches)
    * Communicates clearly with the Ops Supervisor, Technical Leads - Clean room and Operational experts to highlight on production status or any items related to safety, quality and efficiency
    * Uses various manufacturing execution systems (e.g. eLiMS, MES, SAP), and supports to testing and implementation of these.
    * Works in a constructive and flexible way in a team

    This is the profile of a Laboratory Technician:

    • 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.

    This is the offer for a Laboratory Technician:

    • 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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