Process EngineerThe Autumn Group LLC • Chelsea, MA, United States
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Process Engineer
The Autumn Group LLC • Chelsea, MA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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 . 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. 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 .
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
Day-to-Day
Candidate Profile
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Engineer • Chelsea, MA, United States
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