The Process Engineer, reporting to the Manufacturing Operations Manager, takes responsibility and ownership for all activities associated with their assigned Product steps.
- Ensures manufacturing operations are continually supported and maintained in compliance with all quality, safety and environmental regulations.
- Technical transfer, Scale-up & Installation of new processes & new unit operations onto and with-in the plant.
- Support Process & Facility start-ups, initial campaigns & process optimizations.
- Complete detailed Equipment and Process assessments.
- Project Management of wide scope cross functional projects.
- Application of Six Sigma and Lean methodologies when undertaking projects and coaching others in use of these tools as part of their application.
- Ensure campaign preparations for individual processes are achieved to facilitate on‐time campaign start‐up and adherence of agreed production rate.
- Lead cross functional investigations within operations. Use lean six sigma tools to drive root cause analysis and CAPA completion.
- The preparation and routine review of Batch Records, Cleaning Procedures, Equipment Operating Procedures, Standard Operating Procedures, Protocols and Summary Reports. These updates include actively making changes to drive improvements, increase in RFT and decrease in deviations.
- The development and update of control system recipes.
- Participation in audits, quality monitoring inspections and self-inspections as required.
- Participation and driving of Continuous Improvement Activities - including the continuous development and improvement of Documentation, Standards and Processes.
- Lead EHS activities including Process HAZOP or wider safety initiatives.
- Preparation of change control packages (incl. those for International and US Markets).
You will have:
- Degree in Chemical/Process Engineering or Chemistry.
- 3 to 5 years experience in a technical role in the API/Pharma/Biologics industry.
- Experience of technology transfer and a new product/equipment start-up.
To discover more about this opportunity, apply now or contact Emma Mullen at HRM on 087 6369263 for a confidential discussion.