Process Engineer

PROCHEM Engineering

Waterford, Ireland

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.