JOBS

Back

Technical Service – Metrology 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 Metrology Specialist is is supporting Production, QC and logistics activities by performing coordination, field interventions and by ensuring continuity in equipment management. This responsibility covers, but is not limited to :

Technical expertise:

  • 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
  • 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

Communication

  • He/she warns the TS Metrology Supervisor in case of issue
  • He/she maintains an open and effective communication with all departments
  • Takes part to audits when necessary

Planning management:

  • He/she supports equipment qualification activities (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 Catalent Gosselies 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 Catalent Gosselies 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

  • 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.

Offer

For more information please contact to Catalent

Contact Details

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