About the Opportunity
Process Engineering Lead to new product introduction project for the Pre Filled Syringe (PFS) line for the aseptic processing of monoclonal antibody (mAb) - to support technology transfer of new products and to work as part of a highly focused and integrated Process Engineering Team in a Sterile Manufacturing environment.
The main area of work is in acting as Process Lead for a new product introduction technology transfer to our site.
Lead process engineer scope of works will involve, but is not limited to:
Filter test development
Fill weight cycle development
Documentation Generation/Execution (eg. Process control strategy, protocols and FMEAs)
Additionally, the role may require supporting day-to-day operations of the syringe filling/inspection 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 (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) 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 Sanofi 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.
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.
If youre interested please apply or send your CV firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Reference: JO-2205-492280
Website: Cpl Life Sciences
- Posted: 11th May 2022
- Expires: 8th June 2022