Process Engineer, Downstream Tech Transfer

About the role

Support downstream process tech transfer activities from sending site or process development into GMP manufacturing, including protocol and report support, batch record review, and technical input to run readiness.

Responsibilities

• Author deviation technical impact assessments: evaluate process excursions against validated ranges and product quality attributes, and write the technical justification that supports disposition.
• Draft, compile and support review of manufacturing summary reports, pulling together batch data, process performance and deviation outcomes into a coherent technical narrative.
• Author and review material specifications for downstream raw materials, buffers, resins and consumables.
• Perform process data review and trending across downstream unit operations, and support technical investigations arising from campaign execution.
• Interface with manufacturing, QA and process development to close documentation on schedule.

Requirements

• BS or MS in chemical engineering, biochemical engineering, biotechnology or a related discipline.
• 5 or more years of process engineering or MS&T experience in biologics drug substance manufacturing, in a GMP environment.
• Hands-on technical knowledge of downstream unit operations: chromatography, depth and sterile filtration, viral clearance, tangential flow filtration and bulk drug substance handling.
• Demonstrated authoring of deviation technical impact assessments or equivalent investigation documentation that passed QA review.
• Direct tech transfer experience, either sending or receiving site, on at least one biologics process.
• Strong technical writing; this role is documentation‑heavy and writing quality is a primary screening criterion.

Qualifications

• Preferred: CDMO or multi‑client manufacturing experience,