The Autumn Group
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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Management and Manufacturing
Industries Civil Engineering
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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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Management and Manufacturing
Industries Civil Engineering
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