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Technical Service – Infrastructure Specialist (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 Infrastructure Specialist is supporting maintenance/repair activities linked to the entire Catalent Gosselies facility and ensuring continuity in utilities management. This responsibility covers, but is not limited to :

Technical expertise:

  • Support maintenance/repair activities linked to the entire Masthercell facility ; such as HVAC, utilities, power supply, …
  • Ensure follow-up of routine activities linked to the correct working of the entire facility
  • Support facility shutdown periods with the collaboration of the different stakeholders (Production, QA, QC, Supply Chain and sub-contractors)
  • Ensure follow-up of troubleshooting operations for the entire facility
  • Be a Subject Matter expert in the industrial maintenance field
  • Support correct monitoring of entire facility, through the GTC system (Gestion Technique Centralisée) / or equivalent
  • Follow Preventive Maintenance plans
  • Actively participate to problem solving and solutions proposal, with appropriate GMP documentation
  • Be a back-up for the day-to-day activities performed in the Technical Service department.
  • Support techno-vigilance into his field of competencies
  • Communication
  • He/she warns the TS Technical Leader in case of issue
  • He/she maintains an open and effective communication with all departments, with particular attention during facility shutdown periods
  • Takes part to audits when necessary
  • Planning management:
  • He/she supports facility shutdown periods (including maintenance and requalification’s activities), in accordance with initial agreed planning’s
  • He/she follows the action log related to troubleshooting/repair actions he is leading and respects the timelines
  • Actively participates to regular meetings to ensure the follow-up of all tasks linked to his activities
  • Ensures respect of KPI

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/reviewer) 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 feeds and supports initiatives in Environment Health and Safety protecting life and well being

Candidate profile

  • At least, 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.
  • Recognized expertise of GMP requirements (Minimum 2 years of experience in GMP)
  • Good knowledge of Catalent Gosselies Quality System, facilities, process,
  • Knowledge of continuous improvement tools.
  • Problem solving capabilities
  • Efficient communicator and sense of ethic
  • Quality minded, rigorous and customer oriented
  • Demonstrated cross functional team spirit.
  • Pragmatic and action oriented
  • Very good writing skills in French and English.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • ·Delivers Results
  • ·Leads with Integrity and Respect
  • ·Demonstrates Business Acumen
  • ·Fosters Collaboration and Teamwork
  • ·Champions Change
  • ·Engages and Inspires
  • ·Coaches and Develops

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