Job Details

 

 Job Summary

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  • Job Title: Process Technicians
  • Job Code: SA-PFE-PL-0084
  • Job Location: Andover, MA 01810
  • Job Date: 11/11/2021
  • Duration: 12 Months
  • First Shift: 08:00 am - 05:00 pm
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 Job Description

SourceAbled is currently seeking candidates for a potential upcoming role as a Process Technician. This is your opportunity to be one of the first to apply for this anticipated position. The Process Technician supports the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule.  The Process Technician will work on interdisciplinary teams, to implement process improvements, and participate in process troubleshooting

Candidates with autism, neurodivergence and/or disabilities highly encouraged to apply.


Position Tasks

  • Supports 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.
  • Supports the implementation 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 and the timely review of daily documentation
  • Supports data entry
  • Monitors, Identifies and/or communicates 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
  • 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.
  • Must take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.

Education/Experience Required

  • High School diploma required.
  • Experience in a GMP manufacturing environment is desired

Preferred/Not Required
  • Familiarity and experience with either purification processes or mammalian cell culture.
  • Support operations (such as solution preparation and/or operation of autoclav ovens or depyrogenation ovens) is not essential, but is highly desirable.
  • The ability to execute against SOP’s and document entries in a cGMP compliant manner.
  • Ability to interpret and prioritize workflow to maintain the production schedule.

Physical Requirements

  • Requires the moving of heavy equipment and the ability to lift ~50 pounds.

Non-Standard Work Schedule, Travel or Environment Requirements
  • Shift start and end time may be staggered across a shift team to provide wider coverage across the operational day. .
    • 1st shift 8am – 4:30pm, Monday - Friday
    • 2nd shift 3:30pm – 12:00am, Monday – Friday
    • Rotating A/B 1st Shift and 2nd Shift may also be required during startup and training or as needed.
    • Off-shift coverage may be required.

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