Supports manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors, fermentors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
Supports the execution of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.
Supports the execution and issue resolution 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, the timely review of daily documentation and supports data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.
Implements any audit observation improvements.
View Role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
Assists the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
Responsible for remaining current on training programs in support of manufacturing processes.
Supports Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
Interacts with manufacturing asset in support of manufacturing campaigns.
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 manufacturing equipment.
Adequate in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
Assists production sustainability through the performance of inventory accuracy, reconciliation and/or task prioritization to maintain metric adherence.