Process Engineering Development Specialist

UniD is a Contract & Development Manufacturing Organization dedicated to Micro Implants for the controlled release of drugs. Its brand-new facility with its tailormade equipment & technologies allows to handle extrusion, co-extrusion as well as injection moulding-based products. Clients can benefit from unique services going from Proof of Concept to commercial manufacturing.

To manage the engineering and industrialization activities associated to the manufacturing processes that support customers development projects, UniD is hiring a Process Engineering Development Specialist.

Your responsibilities:

The Process Engineering Development Specialist is responsible of the following:

  • Elaborate and execute the process engineering/industrialization development plans/work packages for assigned customers’ projects (external/internal) in line with the global strategies/objectives defined by their N+1.
  • Ensure integration of department drivers (e.g., equipment/lines capacity objectives, screening, cost, timing…) within their projects’ process engineering development activities.
  • Pro-actively communicate relevant projects’ risks identified to their N+1, Product Development team and/or Project Manager when appropriate.
  • Ensures compliance with EHS / quality/ regulatory/ legal requirements of the process development, within his/her scope of responsibilities.
  • Efficiently coordinate and follow up with the operational departments/subcontractors the execution of the process development activities (support, training, planning, follow up, data reporting and analysis…).
  • Provide technical expertise support to operations in case of troubleshooting (e.g., quality event investigations, trending, technology/equipment optimization….), changes or transfer, when relevant.
  • Participate to the process engineering intelligence and continuous improvement program (identification of new process technologies, industrialization, improvements to existing processes…).
  • Edit documents related to process development activities (protocols, reports…).
  • Collaborate with the Product Development team in the definition of the study designs for the manufacturing process part.
  • Attend to technical meetings with customers and to project committee meetings for manufacturing process topics and ensures actions follow up, where assigned by their N+1.
  • Contribute to internal projects programs as per defined by the strategic committee.
  • Participle to product data management process and review.
 Your responsibilities:

Your profile:

  • Master’s degree in engineering or equivalent.
  • At least 10 years of experience in the pharmaceutical or medical device industry.
  • Technical expertise and know-how of process systems in pharmaceutical industries.
  • Experience in pharmaceutical process industrialization.
  • Knowledge of specific pharmaceutical rules applicable to manufacturing process development, qualification/validation and transfer.
  • Knowledge of packaging process engineering is a plus
  • Long term industrialization vision capacity.
  • Autonomous
  • Rigorous
  • Pragmatic
  • Factual/data-based decision making
  • Strong analytical and problem-solving skills and results-oriented
  • Team player, able to work both independently and in a team environment.
  • Open minded and curious
  • Agility
  • Integrity
  • Caring
  • Good communication skills
  • Fluent in English and French (spoken/written)
  • Proactive and willing to work in a start-up environment.
Your profile: