Process Development Technician - II - USD

USA - Process Development Technician - II - USD (Contract)

Andover, MA, United States (On-site)

Contract (8 months 1 day)

Published 2 days ago

/DF, Bioreactors, manufacturing, GMP, CIP

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 works on interdisciplinary self-directed teams to define and implement process improvements, participate in process troubleshooting.

Rotating days 1st or 2nd shift, 6a‑6p, or 2p‑2a

• 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 SOPs for unit operations including but not limited to CIPs, SIPs, Sanitization, etc.
• Implements 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 first‑time right execution, timely review of daily documentation, and data entry; monitors, identifies and/or communicates process and compliance trends in real time.
• Supports the assigned audit lead for walkthroughs/GMP
  100s and observation improvements.
• Views roles 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; facilitates 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 or 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.

• HSD or GED;
  Bachelor's degree preferred with 1‑3 years of relevant experience.
• Downstream experience preferred.

• Min Pay Rate: $24
• Max Pay Rate: $29
• Currency: USD
• Unit: hourly

• Comprehensive Benefits Package available based on eligibility
• Short‑Term Disability (STD)
• Long‑Term Disability (LTD)
• Supplemental and Voluntary Life Insurance