Metrology & Infrastructure Manager

工作内容

Description de l’emploi
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

This Responsibility Covers, But Is Not Limited To

The Equipment & Infrastructure Manager is responsible of overall Equipment and Infrastructure aspects within the Technical Service department.

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 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.