UCB PHARMA SA : GENE THERAPY BIOPROCESS SYSTEMS ENGINEER (F/H)

Offre postée le 14/10/2021

Volontariat International en Entreprise (V.I.E) - Bruxelles, Belgique

Présentation de la société : UCB PHARMA SA

UCB est une entreprise biopharmaceutique internationale ayant pour activités principales la recherche, le développement et la commercialisation de produits pharmaceutiques et biotechnologiques. Elle est spécialisée dans la recherche de solutions thérapeutiques pour des patients souffrant de maladies sévères, traitées par des spécialistes, plus particulièrement dans le domaine du système nerveux central (en ce compris l'épilepsie) et des inflammations (y compris les allergies) .
Le site de Braine-l’Alleud est spécialisé dans la synthèse chimique, le développement, la fabrication et le conditionnement de produits pharmaceutiques

Missions

  • Act as Gene Therapy Bioprocess Engineering SME for facility and equipment design and qualification
  • Support design and qualification of DS process equipment.:
  • Generation of Risk assessments and user specifications for manufacturing systems and single-use materials.
  • Design verification
  • FAT and SAT
  • IQ/OQ
  • Media batches
  • Support transfer of new processes and technologies while ensuring operational excellence and cGMP compliance.
  • Closely collaborate with maintenance and metrology for lifecycle management of equipment.
  • Generation of relevant documentation such as Process Descriptions, SOPs and risk assessments to implement new processes to clinical manufacturing.
  • Floor support
  • Trending and analysis of manufacturing data and generation of campaign reports. Support establishment of appropriate data management systems for knowledge management.
  • Support of regulatory filings and application of Quality-by Design (QbD) principles
  • Support continuous digitalization of the clinical manufacturing plant.
  • Support continuous process optimization, implementation of new technologies and operational improvements in close collaboration with process development
  • Support root-cause investigations, change controls, CAPA plan implementations in close collaboration with the QA department
  • Author and review comprehensive and accurate technology and manufacturing documentation, procedures, specifications and protocols/reports

Profil recherché

Master’s degree in Engineering/Sciences (chemistry, biotech, sciences)
Good technical knowledge of biologics manufacturing, specifically of the DS manufacturing (upstream-and downstream) . AAV manufacturing and/or process development experience would be highly beneficial.
Familiarity with distributed control system (DCS) , specifically PCS7, is highly beneficial.
Hand-on experience with mammalian cell culture- and/or purification systems.
Knowledge/Experience of/in sterility concepts, bioburden reduction approaches, including systematic troubleshooting.
Good knowledge of equipment qualification principles and ASTM E2500
Prioritization and time management skills.
Industrial experience (chemical, pharmaceutical or biotech) with equipment and facilities of pilot scale or higher highly beneficial.
Project management skills would be highly beneficial.
Interpersonal skills to communicate and maintain good working relationship with internal costumers and external contacts/costumers.
Fluent in French and English
Ability solve problems for process issues related to manufacturing process or to facility design.
Ability to prioritize project work and make effective use of available resource.
Ability to apply learning to other projects/situations

Caractéristiques

  • Contrat : Volontariat International en Entreprise (V.I.E) (12 mois)
  • Localisation : Bruxelles, Belgique
  • Niveau d'études : Bac+5 (Master / Ingénieur)
  • Métier : Ingénierie et études : Biomédical

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