-
Supports manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
-
Follow SOPs and batch records for unit operations.
-
Supports operation of manufacturing equipment associated with process equipment commissioning, qualification and validation.
-
Assists troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
-
Strives for Right first time execution and continuous improvement, the timely review of daily documentation and completes data entry; Identify and/or Communicate process and compliance concerns in real time.
-
Participate in audits, as required.
-
Assists the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
-
Responsible for remaining current on assigned training.
-
Supports Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
-
Assists in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
-
Escalates the need for work requests when issues arise with facility/manufacturing equipment.
-
Utilizes enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
-
Assists in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner.