Eir evo talent are currently partnering with a leading BioPharma organisation in Waterford, in the search for a 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:
o Filter test development and optimization of fill weight cycles
o Cleaning verification to ensure high operational hygiene standards
o Lead technical investigations and implement corrective actions for process-related issues
* Documentation and Compliance:
o Develop and execute key process documents including protocols, reports, recipes, and Failure Mode Effect Analysis (FMEAs)
o Author operational control strategy documents and facilitate operator training
* Project Management and Coordination:
o Manage deliverables to meet project timelines and budgets
o Generate detailed schedules for production activities and project planning
* Operational and Vendor Support:
o Support syringe filling processes involving critical equipment such as debaggers, Ebeam, delid/deline systems, isolators, and syringe filling machines
o Liaise with material/component vendors to ensure proper integration and execution of projects
* Safety and Compliance:
o Ensure compliance with Good Manufacturing Practices (cGMP) and safety standards
o Participate in regulatory and safety audits and maintain an audit-ready work environment
What You’ll Bring:
* Educational Requirements:
o Honours degree in an Engineering discipline
* Experience and Skills:
o 3+ years of relevant experience in a regulated GMP environment
o Strong problem-solving and troubleshooting abilities
o Prior experience in sterile manufacturing and syringe filling is an advantage
o Experience in new product introductions or technology transfers is highly beneficial
* Key Attributes:
o Strong project management and communication skills
o Ability to collaborate across departments and with external vendors
o 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
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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.
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