Process Engineer API

Role Description

The Client

My Client is one of Irelands largest pharmaceutical manufacturers. Based in Co Down, but with locations globally, they require an Process Engineer to join their engineering Team.

The Role

Based within the Engineering & Maintenance department the Process Engineer will be responsible for providing design, operational & process safety support to API manufacturing facilities across all sites.

  • Develop PFDs, P&IDs, Material & Energy Balance, URS, and update existing engineering documents with relevant changes. Maintain a drawing register for all modifications to process, mechanical, equipment and controls.
  • Provide engineering support to manufacturing department for day to day production of chemically synthesized active pharmaceutical drug substance and NPIs.
  • Act as an SME for critical unit operations (e.g. chemical reactions, solid/liquid separations, drying, solvent recovery) and process equipment’s.
  • Investigate process, safety incidents, and deviations using Root Cause Analysis techniques.
  • Understand and comply with the Client’s Change Management process. Use TrackWise / CAPA to document and manage change.
  • Take ownership of assigned new projects from concept and scope definition, through design phase and approvals – ensuring that design is fit-for-purpose, meets all EHS and GMP regulations and can be delivered within the constraints of manufacturing.
  • Ensure safety by design on all responsible projects, work closely with CDM co-ordinator and take on principle designer role where applicable – drive Safety excellence.
  • Lead and ensure adequate risk assessment tools (What-If/HAZOP/LOPA/FMEA) are used to assess existing processes and proposed changes to plant, process & equipment’s and take actions to eliminate any potential hazards.
  • Lead DSEAR / ATEX risk assessments, Hazardous Area Classifications, improvements and provide training for the other staff.
  • Work closely with Maintenance department to improve effectiveness and ensure adherence to site Planned maintenance systems.
  • Deliver the implementation of Process Excellence program by identifying, leading and implementing process improvements. Use continuous improvement tools (Lean, 6Sigma) to drive process improvements and cost reduction activities delivering a minimum of two Projects per annum.

The Person

  • Master’s degree in Chemical Engineering
  • Knowledge of Good Manufacturing Practices (GMP) and HSE regulations
  • Experience in design & operation of chemically synthesized Active Pharmaceutical Ingredient manufacturing facility
  • Experience in day to day pharmaceutical plant/ equipment engineering support
  • Experience in implementation of capital projects

To discuss this on any other role in Life Sciences, call Seamus on 02890725625

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