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Process Engineer
Process EngineerThe Autumn Group LLC • Chelsea, MA, United States
Process Engineer

Process Engineer

The Autumn Group LLC • Chelsea, MA, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Process Validation Engineer

Role Focus

  • Primarily a Process Validation role with emphasis on Aseptic Process Simulations (Client) .
  • Still some equipment validation exposure , but Client and process validation experience are the priority.
  • Hands-on execution focus : protocol execution, document deliverables, and revisions - not a lead engineer role.

Team & Environment

  • Team works in a project-based cycle - as one project closes, another opens.
  • in a fast expansion phase , phasing into commercial manufacturing (capital-heavy work).
  • Will collaborate with Quality Operations, Manufacturing, and Lab teams .
  • Day-to-Day

  • Active involvement in Client activities (though not continuous, they come in waves).
  • Supporting process simulations, PPQ starts, and validation deliverables .
  • Mix of execution and documentation : physical GMP documentation (no electronic system yet).
  • Not building from scratch - working with existing benchtop and commercial off-the-shelf systems (e.g., 3L scale equipment).
  • Occasional off-shift hours (7-3 or 2-10) during critical executions, with advance notice.
  • Candidate Profile

  • Ideally 5-8 years of validation experience - must be able to contribute without heavy hand-holding.
  • Strong GMP knowledge and ability to "hit the floor running."
  • Aseptic background required - experience with Client, processing, MSAT teams, process engineering, or manufacturing support is ideal.
  • Experience in fast-paced, expanding environments (e.g., commercial buildouts) is a plus.
  • Doesn't need HPLC / analytical specialty - role is more about process / production validation experience .
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    Engineer • Chelsea, MA, United States

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