About the Opportunity
To provide Process Engineering support to the Pre Filled Syringe (PFS) line for the aseptic processing of monoclonal antibody (mAb) commercial products, 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.
Support commercial manufacturing through delivery of key performance metrics (SQDCI).
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.
The main area of work would be on the Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
Provide engineering support to other areas of the PFS process such as Dispensing, Formulation, filling and continuous improvement project .
Provide technical support to implement process improvements, new product transfers to the site and production.
Provide support to projects within the PFS manufacturing area
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.
If youre interested please apply or send your CV email@example.com
- Agency: Cpl Life Sciences
- Reference: JO-2205-492281
Website: Cpl Life Sciences
- Posted: 11th May 2022
- Expires: 8th June 2022