Process Engineer

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.
• 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.

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

Please note, we do not require agency assistance with this role.