Job Description
Duties:
The Senior Engineer, Equipment is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems.
This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment.
Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover.
Might also own change control and participate in deviation/risk assessment activities.
Manage medium in size and complexity equipment related projects.
Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.
Technical Expertise
Experience and knowledge with process systems and equipment within the following areas: Bioreactors, Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP, Fill...
The Senior Engineer, Equipment is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems.
This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment.
Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover.
Might also own change control and participate in deviation/risk assessment activities.
Manage medium in size and complexity equipment related projects.
Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.
Technical Expertise
Experience and knowledge with process systems and equipment within the following areas: Bioreactors, Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP, Fill...