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Equipment Expert (M/F)

June 9th 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies to the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

 

  • Acts as interface with sub-contractor for production relevant matters in partnership with Producer and Technical Service.
  • Is involved in the equipment management in partnership with Technical Service and Production.
  • Writes or updates generic production equipment URS, (re)qualification (IQ OQ) protocol of specific equipment and PQ of generic equipment.
  • Is consulted for equipment selection, orders specific equipment.
  • Realizes FAT/SAT/IQ/OQ/PQ and generates reports for specific equipment; and eventually for generic equipment.
  • Can help TS to realize preventive maintenance / requalification / calibration on due time.
  • Asks for curative maintenance intervention.
  • Creates, makes available, verifies and archives production equipment logbooks.
  • Manages, orders, makes available clean rooms furniture.
  • Manages utilities in clean rooms.
  • Is involved in modification and improvement of current areas, and in their requalification.
  • Brings production input for new facilities design and participates in new facilities qualification.
  • Compiles weekly equipment project occupation and makes available the list to “on duty” person.
  • Ensures transversal and generic process validation (as VHP) by protocol writing, realization and reports generation.
  • Generates (responsible) and/or ensures finalization (accountable/owner) and/or approves generic and transversal documentation as policies/procedures/instructions/forms/protocols which could be eventually approved by Supervisor and relevant stakeholder.
  • Creates and delivers generic equipment use instructions.
  • Is qualified for Gowning grade A/B.
  • Respects EHS rules in working area: watches for safety aspects in relation with equipment and facilities and directly interacts with safety advisor.
  • Ensures sufficient back-up for activities under his/her responsibilities.
  • Benchmarked best practices from external companies.

Quality:

  • For his/her direct responsibility, ensures cGMP implementation through MTC’s quality system and feeds continuous quality improvement.
  • Documents his/her work according to current procedures and GMP.
  • Is involved in preparation and execution of any audits/inspection.
  • Supports change control preparation.
  • Initiates and finalizes Deviations (Owner role) and CAPA for hierarchy approval. When transversal (on top of the specific field) actions to close Deviations or CAPA are identified, the expert is able to evaluate impacts across MTC on top of its own responsibility field.
  • Is trained for realized activities according to requirements.
  • Ensures continuous improvement in her/his field and beyond, in particular in establishing/compiling KPI.

People:

  • Can functionally manage Production Supports in Shared Service: ensures adequate repartition of work for production supports, being aligned with Shared Service supervisor and other Shared Service Experts.

 

Candidate profile

OBLIGATORY REQUIREMENTS

  • Minimum Master degree in biology, pharmacy, clinical chemistry, bioengineering or relevant experience in a similar position in the sector of Biotech/Pharma/Cell therapy.
  • At least 5 years of experience in GMP environment and Aseptic production, in validation positions.

USEFUL REQUIREMENTS

  • Fluency in French.
  • Good reading, speaking and writing skills in English is a must.
  • Quality minded, rigorous, customer oriented and continuous improvement driven.
  • Demonstrated cross functional team spirit.
  • Organization skills, multitasking, flexibility and autonomous.
  • Good communicator.
     

Offer

 

  • Full-time position (40h/week).
  • An indeterminate contract.
  • The opportunity to take part in a growing dynamic biotech company.
  • A human-sized working environment with a convivial atmosphere.

Contact Details

To apply for this job, please send your application on the following link : MaSTherCell