Process Development Technician - II

ROLE SUMMARY
The Senior Process Techniciandrives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Senior Process Technician will work on interdisciplinary self-directed teams, to define and implement process improvements, participate in process troubleshooting.

ROLE RESPONSIBILITIES
Executes manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
Executes the execution of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.
Implements the execution and issue resolution associated with process equipment commissioning, qualification and validation.
Drives troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
Drives for Right first time execution, the timely review of daily documentation and executes data entry;Monitor, Identify and/or Communicate process and compliance trends in real time.
Supports the assigned audit lead for walkthroughs/GMP100s and observation improvements.
View Role for controlled documentation;SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
Responsible for remaining current and reviews curriculum for training programs in support of manufacturing processes.
Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives;facilitate the drive towards continuous improvement in all manufacturing areas.
Collaborateswith cross-functional manufacturing assets in support of manufacturing campaigns.
Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
Ensures work requests are generated when issues arise with manufacturing equipment.
Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
Operates production sustainability through the performance of inventory accuracy, reconciliation and/or task prioritization to maintain metric adherence.