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Technical Service Metrology Specialist (H/F)

May 11th 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

In general the Metrology Specialist is supporting Production, QC and logistics activities by performing coordination, field interventions and by ensuring continuity in equipment management.

Specific Tasks

The Metrology Specialist is a :

  • Support of facility in terms of preventive and curative maintenance, alarm management and utilities management.
  • Leader of all new equipment and their installation in the facility. This covers periodic requalification and problem solving with current equipment/process and requires entries in clean rooms if needed.
  • Leader for the PROD and QC department in facilitating their day to day operations with equipment.
  • Interface for Environmental Monitoring System.

The Metrology Specialist is leading all equipment and their commissioning with users (Subject Matter Expert) by:

  • Writing and updating documents associated to equipment management (ie: URS, PQ protocols).
  • Ensuring Follow-up of sub-contractors: he/she is coordinating their planning of interventions with users in logistic, Production & QC (ie: installation, requalification, preventative and curative maintenance).
  • Being first line contact point in Technical Service for subject matter experts (SME).
  • Maintaining equipment database up-to-date.

Quality:

  • For his/her direct responsibility, he/she ensures cGMP implementation through MTC’s quality system and feeds continuous quality improvement.
  • He/she Documents his/her work according to current procedures and GMP.
  • He/She is involved in preparation and execution of any audits/inspection.
  • Supports change control preparation.
  • He/She 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.
  • He/She is trained for required activities and is providing data for relevant KPI.

People:

  • He/she maintains opened and effective communication with all other departments.

Safety:

  • He/she operates in safe conditions and following EHS rules in place.

Candidate profile

OBLIGATORY REQUIREMENTS

  • At least, Engineer in Science (e.g. : in biology, pharmacy, clinical chemistry, bioengineering) or relevant experience in a similar position in the sector of Biotech/Pharma/Cell therapy.
  • Minimum 4 years of experience in GMP environment .
  • Aseptic production is a plus.

USEFUL REQUIREMENTS

  • Technical oriented.
  • Quality minded, rigorous, customer oriented and continuous improvement driven.
  • Demonstrated cross functional team spirit.
  • Organization skills, multitasking, flexibility and autonomous.
  • Good communicator.
  • Computer skills : Microsoft Office, use of Data Base systems.

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 : https://bit.ly/3drbw1k