Job Title: Process Development Technician - II Location: Andover, MA Duration: 8 months
Role Summary: The Senior Process Technician drives 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.
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 25.48/daily.
