Elusav Recruitment have an amazing opportunity for a Process Engineer with a leading global biopharma company in Waterford, Ireland.

As Process Engineer, you will be responsible for providing support to the Pre filled syringe (PFS) & Multi Format Filling Line (MFFL) line for the aseptic processing of monoclonal antibody (mAb) commercial products. You will support technology transfer of new products and work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

Responsibilities:

• 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/ MFFL process such as Filling, Formulation, Autoclaving and Washing.
• Provide technical support to implement process improvements, new product transfers to the site and production.
• Support commercial manufacturing through delivery of key performance metrics (SQDCI).

Requirements:

• Manufacturing engineering experience in a highly regulated GMP environment.
• Degree in an Engineering discipline.
• Strong documentation/protocol generation and execution skills.

Contact:

If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on [email protected] or +3536959993.