Process Engineer - Pharmaceutical
Eir evo talent is partnering with a leading Bio Pharma organisation in Waterford to find a dynamic Process Engineer.
Key Responsibilities:
* Develop and optimize processes for pre-filled syringe production, including filter test development and optimization of fill weight cycles.
* Ensure high operational hygiene standards by verifying cleaning procedures.
* Lead technical investigations and implement corrective actions for process-related issues.
Documentation and Compliance:
* Develop 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 (c GMP) and safety standards.
* Participate in regulatory and safety audits and maintain an audit-ready work environment.
Requirements:
* Honours degree in an Engineering discipline.
* 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.