Process Technician

Job Post Index 225436-Sy##
Location Andover, MA
Description: Job Description
  • Supports manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors, fermentors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
  • Supports the execution of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.
  • Supports the execution and issue resolution associated with process equipment commissioning, qualification and validation.
  • Assists troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
  • Strives for Right first time execution, the timely review of daily documentation and supports data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.
  • Implements any audit observation improvements.
  • View Role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
  • Assists the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
  • Responsible for remaining current on training programs in support of manufacturing processes.
  • Supports Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
  • Interacts with manufacturing asset in support of manufacturing campaigns.
  • Assists in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
  • Escalates the need for work requests when issues arise with manufacturing equipment.
  • Adequate in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
  • Assists production sustainability through the performance of inventory accuracy, reconciliation and/or task prioritization to maintain metric adherence.
Skills: Qualifications
  • Associates Degree Required
  • BS Degree preferred
  • 1-3 years of experience
  • Cell Culture experience required (1-2 years)
  • CIPs, SIPs, Sanitization, GMP, GLP knowledge required (1-2 years)
  • Good mechanical knowledge (equipment break down and set up)

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