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Metrology & Infrastructure Manager (H/F/X)

April 13th 2021

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is 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, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

The Role

The Equipment & Infrastructure Manager is responsible of overall Equipment and Infrastructure aspects within the Technical Service department. This responsibility covers, but is not limited to :

Equipment

  • Overall ownership of the equipment database, which must be maintained up-to-date.
  • Organization of the workload within the Equipment Team in order to keep all necessary equipment in a qualified state.
  • Participates to the definition of purchase/installation/qualification strategies of new equipment, in close collaboration with internal customers (Production, QC, QA and IT departments).
  • Ensure that all equipment are maintained/re-qualified correctly, in a timely manner and following appropriate procedures.
  • Anticipate equipment renewal and potential new investments

Infrastructure

  • Overall ownership of the infrastructure database, which must be maintained up-to-date.
  • Organization of the workload within the Infrastructure Team in order to keep all necessary piece of equipment in a correctly maintained state.
  • Ensure shutdown periods are set up in close collaboration between concerned stakeholders (Production, QC, QA and sub-contractors, as appropriate).
  • Ensure that all utilities are maintained/re-qualified correctly, in a timely manner and following appropriate procedures.
  • Anticipate equipment renewal and potential new investments
  • Computerized System Validation
  • Overall ownership of CSV process
  • Ensure correct deployment of CSV process into the different departments
  • Overall ownership of EMS system

Team management

  • Ensures adequate GMP level through his function and contributes to continuous improvement in his department and in the plant
  • Daily coaching and supervision of his team
  • Propose and contributes to fix, follow and reach Key performance Indicators

Technical expertise:

  • He/she is the Subject Matter Expert covering technical questions related to equipment, infrastructure and CSV process

Communication

  • He/she is the interface between the TS department and all other Catalent Gosselies departments and customer for technical aspects related to the equipment and infrastructure management
  • He/she warns the Sr Technical Service Manager in case of issue
  • He/she maintains an open and effective communication with all departments
  • Takes part to audits when necessary

Planning management:

  • Organizes and manages regular meetings with his teams to ensure the follow-up of all tasks linked to their activities
  • He/she supervise maintenance and requalification’s activities, in accordance with initial agreed planning’s
  • He/she supervise the action logs related to troubleshooting/repair actions in order to fulfill expected timelines

Documentation

  • Reviews Catalent Gosselies documents related to his/her activities (protocols, reports, procedures, forms, instructions, …).
  • Participate actively in deviations investigation process

Quality

  • For his/her direct responsibility, he/she ensures cGMP implementation through Catalent Gosselies quality system and feeds continuous quality improvement
  • He/she Documents his/her work according to current procedures and GMP
  • He/she establish appropriate training plans for his team
  • He/She is involved in preparation and execution of any audits/inspection
  • Supports change control preparation
  • He/She finalizes Deviations (reviewer) and CAPA.
  • Trends & continuous improvement:
  • He/she implements and follows-up Key Performance Indicators. He/she proposes and takes appropriate actions
  • He/she implement pertinent tools of operational excellence “Lean culture”

Safety

  • He/she feeds and supports initiatives in Environment Health and Safety protecting life and well being

Candidate profile

  • 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.
  • Recognized seniority expertise of GMP requirements (Minimum 5 years of experience in GMP)
  • Extended knowledge of Catalent Gosselies Quality System, facilities, process,
  • Knowledge of continuous improvement tools.
  • Strategic thinking and problem solving capabilities
  • Efficient communicator and sense of ethic
  • Quality minded, rigorous and customer oriented
  • Demonstrated cross functional team spirit.
  • Pragmatic, action oriented, and decision facilitator
  • ·Very good writing skills in French and English.

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 : Catalent