Role Purpose:
* A new opportunity has arisen for a Process Engineer to join our client’s busy biopharmaceutical facility in Co. Waterford.
* The successful candidate will provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement prefilled syringe processes.
Core Duties and Responsibilities:
* The main area of work is in acting as Process Engineer for project/ programs associated with pre-filled syringe operation. Process engineer scope of works will involve, but is not limited to:
* Filter test development
* Fill weight cycle development
* Cleaning verification
* Documentation Generation/Execution eg. Recipe documents, FMEAs, Protocols, Reports etc.
* Leading problem-solving investigations for technical issues as well as owning change controls.
* Delivering activities on schedule and within budget.
* 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 Company 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.
Education & Qualifications Required:
* Honours degree in an Engineering discipline.
* 3 or more years’ relevant experience in a highly regulated GMP environment.
* Strong problem-solving skills.
* 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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