Metrology Expert

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.

To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated Metrology Expert.

**The Role**

The Metrology Expert 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
- 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 departments in facilitating their day to day operations with equipment.
- Interface for Environmental Monitoring System
- 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).
- 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.
- He/she maintains opened and effective communication with all other departments.
- Takes part to audits when necessary
- He/she operates in safe conditions and following EHS rules in place.
- Planning management:

- He/she leads 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
- 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 4 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 Perfor**mance & Development**:

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

**Position Benefits**
- 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.

**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalen