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Process Engineer

​Faites la différence pour les patients

We are looking for a Process Engineer (Filling) who is dynamic, resilient, and well structured, to join us in our Sterile manufacturing department , based in our UCB office in Braine-l’Alleud, Walloon Brabant, Belgium.

About the role  

As a Process Engineer, you are the technical user representative for projects and/or the project leader within the department for all production activities, mainly all filling-related activities.

-You Support and/or coordinate projects in the sterile manufacturing plant required to deliver BTO's strategy and roadmap, in full scope and on time.

- You Provide technical support to the maintenance team of the sterile manufacturing plant for troubleshooting, equipment investigation, etc.

- Drafting, reviewing and/or approving cGMP documents relating to operations, in compliance with UCB procedures and cGMP guidelines, within the framework of projects.

- Maintaining knowledge of production technology and associated activities (e.g. autoclave, washer, filling equipment).

- Participating in the definition of standard processes and the training of new arrivals.

Who you’ll work with  

This position is part of Braine Technical Operations and directly report to the Head of NPI & Projects of the Sterile Manufacturing Department. You will work closely with the production team, as well as other departments such as Engineering, HSE, Quality Assurance, and Qualification.

What you’ll do   

  • You will develop and maintain a close collaboration with UCB community (Production, Engineering, Quality & HSE) to facilitate and accelerate manufacturing processes transfers & projects into the Sterile Manufacturing Plant.
  • You will keep a technological watch on production techniques (filling machines and associated equipment) to ensure that you always meet regulatory and efficiency requirements.
  • You will be the back-up for the process engineers of the department (incl. the Visual Insp. Process engineer).
  • Projects
  • • You will manage the equipment requirements: define specifications with the project team and coordinate all project activities to deliver on time.

    • You will coordinate/lead projects following the internal governance for project management to maintain project quality, schedule, and budget.

    • You will be responsible for reporting and escalating project risks & issues to management.

    • You will act as change leader for activities required by the projects you are in charge of.

    • You will ensure that all manufacturing and operating documents are available at the handover of the project and the personal is trained.

  • Technical support :
  • • You will provide technical support to the production maintenance for troubleshooting, equipment investigation, etc.

    • You will lead/support technical investigations, deviations and associated CAPA.

    • You will suggest and elaborate optimization & improvement of operational & organizational processes to gain in efficiency and maximize output.

  • Quality & Compliance
  • • You will collaborate closely with the Compliance and Production team and ensure aligned vision on projects, eg. Digitalization.

    • You will act in accordance with GMP compliance in all activities, ensure compliance of all business-related activities.

    • You will maintain all activities in “Permanent Inspection Readiness” mode.

    • You will contribute to achieving the Sterile Manufacturing department’s compliance objectives and indicators.

    • You will write, review and/or approve cGMP documents relative to the department, in compliance with UCB procedures and cGMP guidelines.

  • HSE and Wellbeing
  • • You will stimulate, sponsor and support relevant initiatives into the department, aiming at working in a safer and greener environment.

    • You will apply the company’s Health and Safety policy within the production zone.

    • You will ensure the respect of all applicable legislations (assistance of HSE manager if necessary) eg safety instructions, and make sure to provide the adequate means.

    • You will promote an effective HSE culture and be an example.

    Interested? For this role we’re looking for the following education, experience and skills   

  • You have a master’s degree as Bioengineer, Process Engineer, Mechanical Engineer, Chemical Engineer, Industrial Pharmacist, Chemist, Biologist, or proven experience.
  • You are strongly safety minded and knowledgeable of industry safety standards.
  • You have good knowledge of GMP requirements for sterile product development & manufacturing.
  • You have strong knowledge in aseptic manufacturing practices, bulk filling, aseptic filling.
  • Knowledge in visual inspection processes: manual, semi-automatic, as fully automatic is a plus.
  • You have good knowledge of project management methodology.
  • You have very good interpersonal communication skills to foster collaboration with internal customer and support departments.
  • You are autonomous and rigorous, with an out-of-the-box approach for problem solving and an excellent team working mindset.
  • You have the ability to work in a highly matrixed and dynamic environment.
  • You have the ability to prioritize and organize daily tasks to meet deadlines, remain focused and be proactive (multitasking).
  • You are knowledgeable of innovative and practical solving problems technologies.
  • Êtes-vous prêt à « aller au-delà » pour créer de la valeur et faire la différence pour les patients? Si cela vous parle, alors nous aimerions vous connaitre! 

    À propos de nous 
    UCB est une société biopharmaceutique mondiale, spécialisée dans la neurologie et l'immunologie. Nous sommes environ 8 500 personnes aux quatre coins du monde, inspirées par les patients et motivées par la science. 

    Pourquoi travailler pour nous ? 

    Chez UCB, nous ne nous limitons pas à réaliser des tâches, nous créons de la valeur. Nous ne craignons pas d'aller de l'avant, de collaborer et d'innover pour faire la différence auprès des patients. Nous avons une culture de bienveillance et solidarité où chacun se sent inclus, respecté et a des chances équitables de faire de son mieux. Nous « allons au-delà » pour créer de la valeur pour nos patients, et toujours dans une optique humaine, que ce soit pour nos patients, nos employés ou notre planète. En travaillant pour nous, vous découvrirez un monde où vous pourrez grandir et aurez la liberté de tracer votre propre chemin de carrière et accomplir votre plein potentiel. 

    sur la durabilité chez UCB et comment elle est intégrée dans notre approche commerciale. 

    UCB et ses filiales encouragent la diversité et l'inclusion au travail; Nous sommes un employeur équitable. Nous ne discriminons pas sur la base de la race/la couleur/la religion/le sexe/l'origine nationale/l'ancien combattant/le handicap/l'âge/l'orientation sexuelle/l'identité de genre.

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