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Catalent Pharma Solutions Utilities Specialist in Gosselies, Belgium

Description de l'emploi

Technical Service – Infrastructure Specialist

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 Infrastructure Specialist.

The Role

The Infrastructure Specialist is supporting maintenance/repair activities linked to the entire Catalent Gosselies facility and ensuring continuity in utilities management. This responsibility covers, but is not limited to :

  • Technical expertise:

  • Support maintenance/repair activities linked to the entire Masthercell facility ; such as HVAC, utilities, power supply, …

  • Ensure follow-up of routine activities linked to the correct working of the entire facility

  • Support facility shutdown periods with the collaboration of the different stakeholders (Production, QA, QC, Supply Chain and sub-contractors)

  • Ensure follow-up of troubleshooting operations for the entire facility

  • Be a Subject Matter expert in the industrial maintenance field

  • Support correct monitoring of entire facility, through the GTC system (Gestion Technique Centralisée) / or equivalent

  • Follow Preventive Maintenance plans

  • Actively participate to problem solving and solutions proposal, with appropriate GMP documentation

  • Be a back-up for the day-to-day activities performed in the Technical Service department.

  • Support techno-vigilance into his field of competencies

  • Communication

  • He/she warns the TS Technical Leader in case of issue

  • He/she maintains an open and effective communication with all departments, with particular attention during facility shutdown periods

  • Takes part to audits when necessary

  • Planning management:

  • He/she supports facility shutdown periods (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 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/reviewer) 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.

  • People

  • He/she maintains opened and effective communication with all other departments.

  • Safety

  • He/she feeds and supports initiatives in Environment Health and Safety protecting life and well being

The Candidate

  • 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.

    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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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