What are the responsibilities and job description for the Process Engineer position at The Autumn Group?
Process Validation Engineer
Role Focus
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 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.