Process Engineer

Join the Process Engineer role at The Autumn Group.

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.