Eir evo talent are currently partnering with a leading BioPharma organisation in Waterford, in the search fora dynamic Process Engineer to support daily manufacturing functions and drive continuous improvement in pre-filled syringe processes.
In this role, you will be essential to the production of monoclonal antibody (mAb) products, technology transfer, and capacity expansion.
Join a collaborative and high-performing engineering team working in a cutting-edge sterile manufacturing environment.
Key Responsibilities: Process Development and Optimization: Filter test development and optimization of fill weight cycles Cleaning verification to ensure high operational hygiene standards Lead technical investigations and implement corrective actions for process-related issues Documentation and Compliance: Develop and execute key process documents including protocols, reports, recipes, and Failure Mode Effect Analysis (FMEAs) Author operational control strategy documents and facilitate operator training Project Management and Coordination: Manage deliverables to meet project timelines and budgets Generate detailed schedules for production activities and project planning Operational and Vendor Support: Support syringe filling processes involving critical equipment such as debaggers, Ebeam, delid/deline systems, isolators, and syringe filling machines Liaise with material/component vendors to ensure proper integration and execution of projects Safety and Compliance: Ensure compliance with Good Manufacturing Practices (cGMP) and safety standards Participate in regulatory and safety audits and maintain an audit-ready work environment What Youll Bring: Educational Requirements: Honours degree in an Engineering discipline Experience and Skills: 3+ years of relevant experience in a regulated GMP environment Strong problem-solving and troubleshooting abilities Prior experience in sterile manufacturing and syringe filling is an advantage Experience in new product introductions or technology transfers is highly beneficial Key Attributes: Strong project management and communication skills Ability to collaborate across departments and with external vendors A proactive, innovative approach to problem-solving Additional Requirements: Willingness to travel as needed to vendor or client sites Support site performance goals related to Safety, Quality, Delivery, Cost, and Innovation (SQDCI) Ref: EET6626 oOo Candidates must be eligible to work full time and long term in the location specified or currently hold a valid appropriate long term work Visa to apply.
If you are interested in applying for this role, please do so via the relevant link.
If you would like to discuss this role in confidence, please contact Eoghan Conway.
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