Production Support Supervisor (Shared services)

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 Production Support Supervisor.

The Role

Logistic and Environmental Monitoring

• Ensures EM & cleaning conformities and respect of frequencies for all grades
• Ensures grade C/D Environmental Dev & CAPA are well managed and are followed
• Ensures to provide sufficient support to production for the realization of grades B/A major cleaning and monitoring (monthly, quarterly, yearly)
• Guarantees production daily checks of EMS reports are realized
• Ensures that EM trends are analyzed for production matters and that actions are taken for parts under her/his scope
• Ensures rooms & projects inter-campaigns are realized in time with the schedule needs of production and that documentation is well completed
• Ensures VHP are realized and reports are reviewed.
• Ensures consumables ordering for production and other generic furniture
• Guarantees efficient material transfer to classified rooms (grade D or C) and generic consumables stock level in common rooms
• Ensures good interactions with QC concerning EM and with TS concerning logistic
• ll employees are properly trained and equipped in the current process to execute required work.
• Participate in customer and authority audits;
• Drives continuous improvement initiatives and implementation of Operational Excellence

Facilities and equipment

• Is the privileged interface between production and TS
• Guarantees production equipment management in partnership with Technical Service and Production.
• Writes and Approves URS for generic equipment
• Ensures equipment (re)qualification protocol writing under Shared Service responsibility
• Is consulted for equipment selection and accountable of specific equipment ordering
• Ensures adequate qualification of equipment for under Shared Service responsibility
• Follows-up of curative maintenance on defective equipment
• Is accountable of production equipment logbook management
• Guarantees furniture management and utilities management in cleanrooms are well conducted
• Ensures modification and improvement of current areas, and requalification if needed, are well conducted
• Ensures production input for new facilities design is well implemented and new facilities qualification
• Ensures URS writing for transversal and generic processes (as electronic samples storage management) and selection of these systems
• Ensures transversal and generic process are validated (as VHP)
• Ensures LN2 and -80°C freezer occupation, inventory and cleaning status management

Equipment, cleaning, and disinfection validation

• Ensure all generic production equipment are qualified and validated
• Ensure all validation cycle for new equipment
• Ensure cleaning/disinfection method or process are validated and ensure qualification is still up to date
• Ensure cleaning and disinfection agent are qualified and validated.
• Write, review and approve validation/qualification document
• Write, review and approve validation procedure and is able to challenge it
• Write, review and approve change control.

People Management

• Manages Shared Service experts, specialists and production supports
• Approves Time Sheets for Shared Service Production team and manage leaves requests, absences, and extra-hours of Production Shared Service Team, being aligned with other supervisors when needed.
• Ensures appropriate resources allocations to the various projects of Production Department, in collaboration with other supervisors/managers of production
• Shares appropriately work between Shared Service experts, specialist and production supports, according to their competencies and workload
• Ensures his/her team is adequately staffed, trained, equipped (premises, equipment’s and any material) to execute required work. This covering both GMP and EHS aspects
• Guarantees EHS rules are respected
• Ensures individual development plan of his/her team member is in place and followed. Ensures appropriate expertise/polyvalence ratio of the team to cover various needs of Masthercell
• Ensure homogenous team management and coherence between all Shared Service Experts and Production SupportsWrio

The Candidate

• Master’s degree in Sciences or experience in a similar position in the sector of Biotech/Pharma/Cell therapy (GxP environment).
• At least 5 years of experience in cGMP and manufacturing environment
• Previous experience in an aseptic production environment (cell and gene therapy, biotechnology, …).
• Previous experience in validation.
• Previous experience in eEMS system management is a plus.
• Fluent in French and English: excellent speaking, reading, and writing skills.
• IT Skills: MS Office. Knowledge of Documentum, Trackwise, Mirrhia is a plus

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.
• Company car
• 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 distribution de médicaments et aidez-nous à proposer plus de 7 000 produits vitaux aux patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec les sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser les nouveaux médicaments, du développement précoce aux essais cliniques et au marché. Catalent produit plus de 70 milliards de doses par an et chacune d’entre elles sera utilisée par quelqu’un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalent s’engage à assurer la santé et la sécurité de ses employés, ses visiteurs, des clients et patients qu’elle sert. En raison de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d’intégration afin de préserver la sécurité de chacun. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape

Catalent. Plus de produits. De meilleurs traitements. Fournis de manière fiable. ™

Visitez www.catalent.com/careers pour explorer les opportunités de carrière.

Catalent est un employeur favorisant l’égalité des chances et l’action pour l’équité . Tous les candidats qualifiés seront considérés pour un emploi sans distinction de race, de couleur, de religion, de sexe, d’origine nationale, d’incapacité, de statut de vétéran protégé, d’orientation sexuelle ou d’identité de genre. Si vous avez besoin d’une aide raisonna ble pour une partie du processus de candidature ou d’embauche en raison d’un handicap, vous pouvez soumettre votre demande en envoyant un courrier électronique confirmant votre demande d ’adaptation et en indiquant le numéro du poste, le titre et l’emplacement à l’adresse DisabilityAccommodations @ catalent. com. Cette option est réservée aux personnes nécessitant une adaptation en raison d’un handicap. Les informations reçues seront traitées par un employé américain de Catalent, puis acheminées vers un recruteur local qui fournira une assistance pour assurer la prise en compte appropriée du processus de candidature ou d’embauche.

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