My client a leading Pharmaceutical company now require a Process Engineer - API to join their rapidly expanding team.
The Process Engineer reports to the Manufacturing Operations Manager, takes responsibility and ownership for all activities associated with their assigned Product steps.
Their overarching goal is to provide Technical Support within Operations to meet agreed operational targets for safety, quality and customer delivery performance
They will execute restart activities to ensure that all new APIs manufactured at the site are adequately supported in line with company Policies and Global SOP requirements
This is a permanent role based in Wicklow and it comes with a good salary with good benefits.
Responsibilities of Process Engineer - API
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
Takes ownership for assigned process steps and provide process technical support as required
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 cycle time reduction initiatives
Drive EHS activities within Operations including participation in Process HAZOP or wider safety initiatives.
Preparation of change control packages (incl. those for International and US Markets).
Liaise with site Engineering for equipment/control system modification/installation
Requirements of Process Engineer - API:
3 to 5 years' experience in a technical role in the API industry
Degree in Chemical/Process Engineering or Chemistry
Strong leadership, communication, decision making and problem solving skills
Experience with 6 sigma or other operational excellence tools
Experience of working in a cross functional team in a highly regulated environment
Experience of technology transfer and a new product/equipment start-up
An understanding of computer control systems, P.I.D loops and interlock devices
To apply please contact John on firstname.lastname@example.org