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:Filter test development and optimization of fill weight cyclesCleaning verification to ensure high operational hygiene standardsLead technical investigations and implement corrective actions for process-related issuesDocumentation 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 trainingProject Management and Coordination:Manage deliverables to meet project timelines and budgetsGenerate detailed schedules for production activities and project planningOperational and Vendor Support:Support syringe filling processes involving critical equipment such as debaggers, Ebeam, delid/deline systems, isolators, and syringe filling machinesLiaise with material/component vendors to ensure proper integration and execution of projectsSafety and Compliance:Ensure compliance with Good Manufacturing Practices (cGMP) and safety standardsParticipate in regulatory and safety audits and maintain an audit-ready work environmentWhat You'll Bring: Educational Requirements:Honours degree in an Engineering disciplineExperience and Skills:3+ years of relevant experience in a regulated GMP environmentStrong problem-solving and troubleshooting abilitiesPrior experience in sterile manufacturing and syringe filling is an advantageExperience in new product introductions or technology transfers is highly beneficialKey Attributes:Strong project management and communication skillsAbility to collaborate across departments and with external vendorsA proactive, innovative approach to problem-solvingAdditional Requirements: Willingness to travel as needed to vendor or client sitesSupport site performance goals related to Safety, Quality, Delivery, Cost, and Innovation (SQDCI)Ref: EET6719 —oOo— 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. If you are interested in applying for this role, please do so via the relevant link.
If you would like to discuss this role in confidence, please contact Harleen Tora. eir evo talent, eir evo and our clients are equal opportunity employers who seek to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability.
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