Metrology & Infrastructure Manager

Contenuto del lavoro

Technical Service – Equipment & infrastructure Manager

Position Summary

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 Equipment & Infrastructure Manager.

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
  

The Candidate

• 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.
  
  

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
  
  

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.

Catalent s’engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d’intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.

Initiative personnelle. Rythme dynamique. Un travail significatif.

Visitez Catalent Careers pour explorer les opportunités de carrière.

Catalent est un employeur garantissant l’égalité des chances et ne fait aucune discrimination sur la base d’une caractéristique protégée par la législation locale.

Si, en raison d’un handicap, vous avez besoin d’un aménagement raisonnable pour une partie ou plus du processus de candidature ou d’embauche, vous pouvez soumettre votre demande en envoyant un courriel et en confirmant votre demande d’aménagement et en incluant le numéro de poste, le titre et le lieu à DisabilityAccommodations@catalent.com. Cette option est réservée aux personnes ayant besoin d’un aménagement en raison d’un handicap. Les informations reçues seront traitées par un employé de Catalent aux États-Unis, puis acheminées vers un recruteur local qui fournira une assistance pour assurer une prise en compte appropriée dans le processus de candidature ou d’embauche.

Avis aux représentants des agences et des cabinets de recherche : Catalent Pharma Solutions (Catalent) n’accepte pas les curriculum vitae non sollicités d’agences et/ou de cabinets de recherche pour cette offre d’emploi. Les curriculum vitae soumis à tout employé de Catalent par une agence tierce et/ou une société de recherche sans un accord de recherche écrit et signé valide, deviendront la propriété exclusive de Catalent. Aucuns frais ne seront payés si un candidat est embauché pour ce poste à la suite d’une recommandation non sollicitée d’une agence ou d’un cabinet de recherche. Merci.