Job Title: Process Development Technician – II
Job Location: Andover, MA
Job duration: 12 months
Job Location: Andover, MA
Job duration: 12 months
Schedule: This is for the 2nd Shift.
Pay rate: $27.18/hr on w2
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.
- 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.