About the Role
eir evo talent are currently partnering with a leading BioPharma organisation in Waterford to support daily manufacturing functions and drive continuous improvement in pre-filled syringe processes.
Key Responsibilities
* Process Development and Optimization: Develop and optimize filter test development, fill weight cycles, and cleaning verification to ensure high operational hygiene standards.
* Documentation and Compliance: Develop key process documents, including protocols, reports, recipes, and Failure Mode Effect Analysis (FMEAs), and author operational control strategy documents.
* Project Management and Coordination: Manage deliverables to meet project timelines, generate detailed schedules for production activities, and plan projects.
* Operational and Vendor Support: Support syringe filling processes involving critical equipment, liaise with vendors, and 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.
* Skills: Strong problem-solving and troubleshooting abilities, project management and communication skills, ability to collaborate across departments and with external vendors.
About Us
eir evo talent and our clients are equal opportunity employers seeking to recruit and appoint the best available person for a job regardless of marital status, sex, age, religion, belief, race, nationality, or ethnic origin. We apply all relevant Data Protection laws when processing your Personal Data.