Process Engineer

Job Type   /   Job Level

Full-time   /   Junior Executive

Job Location

Boston, MA

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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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