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/GMP
100s 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.
" Collaborates with 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.