JOBS

Back

Technical Service Equipment Specialist(m/f)

November 22nd 2019

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 onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

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

Specific Tasks

The Technical Service Equipment Specialist is a :

  • Support of facility in terms of preventive and curative maintenance, alarm management and utilities management;
  • Support 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;
  • Support for the PROD and QC department in facilitating their day to day operations with equipment;
  • Interface for Environmental Monitoring System.

The Technical Service Equipment Specialist is supporting all equipment and their commissioning with users (Subject Matter Expert) by:

  • 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);
  • 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.

 

Candidate profile

Qualifications & Experience

  • Master 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;
  • At least 3 years of experience in GMP environment and Aseptic production is a plus;
  • Fluency in French;
  • Good reading comprehension and writing skills in English;
  • Computer skills: Microsoft office, use of Data Base systems.

Skills & Competencies

  • Technical oriented;
  • 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

Click on this link to apply : http://bit.ly/35dXTP2