Job Description
Eir evo talent are currently partnering with a leading Bio Pharma organisation in Waterford to support daily manufacturing functions and drive continuous improvement in pre-filled syringe processes.
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.
Requirements
* Education: Honours degree in an Engineering discipline.
* Experience: 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.
Attributes
* Strong project management and communication skills.
* Able to collaborate across departments and with external vendors.
* A proactive, innovative approach to problem-solving.