Process Engineer - Waterford
Hartley People
Waterford, Munster
Our client, a leading manufacturing company based in Waterford currently has a vacancy for a Lead Process Engineer . This is an opportunity to join a leading manufacturing company in a challenging and rewarding role with excellent opportunities for personal development. You will provide Engineering support in the development, operation and improvement of processes associated with aseptic Fill Finish and Lyophilization. You will be the equipment SME for sterile operations and have an in-depth understanding of equipment functionality and process requirements. The Role. Understanding equipment operation in detail. Defining and reviewing equipment specification and associated test documentation. Support project delivery through FAT, SAT and IOQ involvement as needed. Troubleshooting equipment with particular emphasis on process cycles (e.g cleaning, sterilizing. Strong focus on disciplined root cause analysis. Liaising with vendors on pre-sterilized components. Defining specifications and test requirements. Liaising with vendors on disposable technology and integration into the process. Defining specification and test requirements. Development of process cleaning and sterilization cycles. Development of procedures and controls for High Containment applications. Development of Leachable and extractable reports and studies as applicable. Development of critical process parameters for the process and development of process capability and deviation monitoring. Monitoring process risk and ensuring mitigations are in place as required. Implementation of data monitoring systems to ensure process control. The Person. Qualified to a minimum of higher degree level in engineering or related discipline. Minimum 5 years engineering experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment. Ability to understand engineering processes through a logical, data driven, hands on approach. Knowledge of sterile and isolator technologies (including disposable technologies). Have an expertise in Fill Finish critical process parameters and product quality attributes. Experience in Cycle development and validation for sterile manufacturing. cGMP Compliance. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Karrena on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Manufacturing Engineer, Automation Engineer, Project Engineer, Design Engineer, R&D Engineer, Mechanical Engineer, Process Engineer, Plastic Engineer, Chemical Engineer, Engineering Manager, Quality Engineer, Electrical Engineer, Injection Moulding Engineer, Lean Engineer, Validation Engineer, Maintenance Engineer. Will be equipment SME for sterile operations with an indepth understanding of equipment functionality and process requirements.
2737 days ago