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Process Engineer, 3+ yrs Exp. (12M, Waterford), Cork
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Client:
CareerWise Recruitment
Location:
Cork, Ireland
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
d88c1777114b
Job Views:
3
Posted:
16.07.2025
Expiry Date:
30.08.2025
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Job Description:
Job Description
PROCESS ENGINEER with experience of Sterile Manufacturing Operations, Syringe Filling and New Product Introduction required by CareerWise Recruitment for our multinational biopharmaceutical & medical device client in Waterford. Initial 12 month contract on offer.
The PROCESS ENGINEER wil have 3+ years experience and work on Projects / Programs associated with pre-filled syringe operations.
NOTE: It is essential that you hold a valid working visa for Ireland
Scope of works will involve, but is not limited to:
* Leading problem solving investigations for technical issues as well as owning change controls.
* Delivering activities on schedule and within budget.
Responsibilities
* Supporting day-to-day operations of the syringe filling area through investigations, identify and deliver corrective actions including continuous improvement projects.
* Communicate and liaise with material/component vendors during project.
* Execute Process Engineering activities to schedule and to the appropriate compliance and safety standards.
* Writing of Process/Operational Control Strategy documents (detailing control over Critical Process Parameters), Failure Mode Effect Analysis (FMEA) and supporting Operator training.
* Coordinating and ownership of deliverables to meet project timelines and cost.
* Generation of hour-by-hour schedules for planning line time and execution of deliverables.
* Provide support where required on the existing Aseptic Syringe Filling Line and supporting processes which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
* Support commercial manufacturing through delivery of key performance metrics (SQDCI).
* Role may require travel to other sites or vendor sites.
* Participate in site GMP regulatory and safety audits.
* Provide technical support to implement process improvements, new product transfers to the site and production.
Requirements:
* Honours degree in an Engineering discipline.
* 3 or more years’ relevant experience in a highly regulated GMP environment.
* Experience of Sterile Manufacturing Operations would be an advantage.
* Experience in syringe filling would be a distinct advantage.
* Experience in new product introduction would be a distinct advantage.
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