MS&T and PV Formulation and Filling Engineer

The Biologic Manufacturing, Science & Technology and Process Validation Formulation / Filling Engineer is responsible for the technical transfer and/or process development of Biologic drug product formulation and filling, together with the related validation strategy. This position is expected to master downstream development and transfer of drugs (encompassing drug product scale-up for clinical and late state biologics manufacturing), as well as Quality by Design approach to ensure a successful manufacturing process design and validation.

You will work in close collaboration with other groups as Operations, Quality and Project Management Office.

The Role

• Lead technical decisions related to formulation and filling steps development and the related validation strategy
• Perform/coordinate within her/his team multiple complex projects at a time
• Support the site transition towards biological drug manufacturing
• Ensure appropriate hand-over of technical requirement to Operations while Commercial batches are launched
• Be actively part of the Catalent Bio Drug Product Development network
• Initiate, direct and execute technical research and collaboration for innovation, process improvements and process validation
• Plan and conduct work requiring independent judgment in the evaluation, selection, and substantial adaptation/modification of standard techniques, procedures and criteria
• Design new approaches to problems encountered and use a wide application of complex principles, theories and concepts in the specific field
• Interact in a professional way with all the clients in order to decide the best technical solution and validation strategy for each client drug transfer
• Build and maintain relationships with vendors for implementation of new equipment or technologies
• Develop knowledge of scale up principles with respect to formulation, fill & finish
• Develop knowledge on Quality by Design (QbD) approach for Biological Late-Stage manufacturing steps
• Manage and support MS&T and Process Validation Filling & Formulation sub-team to allow them to perform in an efficient and professional way the following activities:
  • Design and implement the process to the detail for new Biologic products on the Brussels site, with a focus on Formulation and Filling manufacturing activities
  • Acts as the technical lead for client development projects, communicates project status internally and externally, and effectively provides technical explanation/rationalization
  • Perform process design for project transfer to production (focus on product characteristics, equipment and facility characteristics, operational efficiency and quality/risk approach)
  • Design, perform and evaluate accuracy studies on a scientific basis, e.g. pumps studies, kinetic studies, etc.
  • Manage Lead Failure Mode and Effect Analysis (FMEA) for the drug product formulation and fill processes
  • Build processes and validation strategy following Quality By Design approach and according to ICH Q8 regulation
  • Manage the Process Validation steps, encompassing the related PPQs sampling strategy;
  • Supervise as per need compatibility studies with the manufacturing process materials, including tubing, bags, filters and final container closure
  • Participate to the execution of matrix design for experiments as a part of defining process operating windows and design space
  • Critically analyzes complex data, interprets and integrates experimental results with project objectives
  • Performs manufacturing overview for client tours and internal clients
  • Assist the project management team to determine timeframe, funding and limitations
  • Identify/verify the Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) , based on the Quality Target Product Profile (QTPP)
  • Participate in the writing of User Requirement Specifications (URS) and internal procedure for specific equipment or part of the process
  • Field support to operation teams during formulation and filling of technical / validation batches (flexible schedule and/or night shifts could be required)
  • Participate in investigation exercise in case of deviation during production
  • Troubleshoot and problem solve in order to initiate and execute/monitor corrective actions
  • Contact with suppliers for implementation of new equipment or technologies
  • Supports internal and external audits
  • Author validation documentation including, but not limited to, Process Validation protocols and reports, Cleaning Validation protocols and reports, and Protocol Discrepancies and Addenda.
  • Investigate deviations as per need and execute corrections and/or develop preventive actions

The Candidate

Education:

• Master in Bio Engineering, or related field with at least 10 years of experience, preferably in a pharmaceutical industrial setting
• Fluency in English and French

Experience:

• Biological drug product Technical transfer
• Biological drug product formulation and filling validation, process scale up, and technology transfer
• Utilization of QbD for designing and validating drug product manufacturing processes
• Extended knowledge and experience working in a cGMP environment
• Aseptic technique experience
• Experience managing staff, coaching, training
• Ability to organize and prioritize work schedules of others on short and long-term bases
• Ability to make decisions which have significant impact on the customers’ transfer/development drug product projects
• Ability to compute, analyze, and interpret complex statistical data.
• Proficient in the operations of a computer with MS-Office, specifically MS Excel and MS word, as well as programs for multiple pieces of laboratory or manufacturing equipment.
• Ability to write SOPs, batch production records and reports independently.
• Ability to provide ideas and introduce new technology for process improvements with the goal of transfer to manufacturing
• Proven leadership and change management skills.
• Ability to adapt to fast paced environment.
• Leadership

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.