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.
- 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
• 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