2025-1275 – Process Engineer – Waterford Contractor

This is a 12 month contract with a view to extension

Purpose

To provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement pre filled syringe processes. Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

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.

Additionally, the role will require:
• 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.
Other responsibilities will be to 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.

Qualifications

• Honours degree in an Engineering discipline.
• Strong problem solving skills.
• 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.