Process Engineer – Automation SME. Arr. Nivelles

Major accountabilities :

• Leadership
  • Lead the Automation topics in process scope
• TECHNICAL SKILLS
  • Understand and translate Automation functional specification to process SME to ensure URS&TRS requirements are fully answered.
  • Strong background within manufacturing M&B(Media and Buffer) or USP or DSP process equipments
  • Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required, as well as mass balances.
  • Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant
  • Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
• URS
  • Review the URS provided by the Engineering Office in order to ensure all User requirements are fully respected
  • Include all technical requests in the URS for the commissioning and qualification.
• DETAILED DESIGNG
  • Review and participate in the technical specs and datasheets from Engineering Office
  • Review Functionnal specification for Automation from Engineering Office
  • Challenge technical solutions coming from Engineering office
  • Integrate safety, sustainability and green assessment in the design
  • Follow-up and challenges of the engineering office
• Commissioning, Qualification&Validation
  • Perform Design review and Design Verification with the Engineering office and the CQV team
  • Lead and Participate to the FAT/SAT of Equipments in the scope
  • Support the qualification phases after commissioning (ASTM2500)
  • Organize quality checks on field before each technical milestone activiy.
  • Ensure a good communication with other Specialists linked to its activity (Battery limits)
  • Maintain his knowledge accuracy based on new technology. Keep up-to-date.
• Documentation
  • Organize the training of the final user in its area of expertise & provide technical documentation in to finalize the Hand-Over
  • Actively perfom the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist
  • Respect documentation strategy
• HSE
  • Ensure compliance to HSE requirements and rules
  • Ensure the 3 green lights are schedulled and correctly organized/done

• Master's degree
• Minimum 15 years of experience within pharmaceutical companies and working with Engineering offices
• Strong knowledge in Automation in PCS7
• Good Knowledge of cGxP requirments
• Manage a fluent communication between different stakeholders (Engineering office, User and others)
• Good teamwork