Job Description:
Eir evo talent is partnering with a leading Bio Pharma organisation in Waterford to find a Process Engineer.
Key Responsibilities:
* Process Development and Optimization: Develop filter test methods, optimize fill weight cycles, and verify cleaning procedures for high operational hygiene standards.
* Documentation and Compliance: Create process documents like protocols, reports, recipes, and Failure Mode Effect Analysis (FMEAs), and author operational control strategy documents.
* Project Management and Coordination: Manage project timelines, generate production activity schedules, and coordinate with vendors.
* Operational and Vendor Support: Support syringe filling processes involving critical equipment, liaise with material/component vendors, and ensure proper integration 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.
You'll Bring:
* Education: Honours degree in an Engineering discipline.
* Experience and Skills: 3+ years of experience in a regulated GMP environment, strong problem-solving abilities, and experience in sterile manufacturing and syringe filling is an advantage.
Attributes:
* Strong project management and communication skills.
* Able to collaborate across departments and with external vendors.
* Proactive, innovative approach to problem-solving.