Process Engineers (Downstream)

Global Compliance Partners; Madison (WI); On-site; USD 95,000 - 150,000; Full time

Job summary

Global Compliance Partners in Madison, WI is hiring two Process Engineers to support the Downstream Tech Transfer group within MS&T. You will help transfer chromatography, filtration and viral clearance steps into GMP manufacturing, compiling documentation and supporting run readiness.

The role emphasizes hands-on process knowledge, technical writing, and collaboration with QA, process development and manufacturing to ensure on-time campaigns.

Qualifications

• BS or MS in chemical engineering, biochemical engineering, biotechnology or a related discipline.
• 5+ 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.

Responsibilities

• 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.
• 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.

Skills

Technical writing

Process engineering

Downstream unit operations

Education

BS/MS in chemical/biochemical/biotech

Tools

Chromatography

Depth filtration

Sterile filtration

Viral clearance

Tangential flow filtration

Bulk drug substance handling

Job description

Global Compliance Partners is a GxP compliance consulting firm supporting cell and gene therapy, biologics and sterile manufacturing organizations from IND through BLA and commercial supply. Our consultants have led GMP launches for approved products and work across CQV, CSV, process validation, MSAT, analytical, quality systems and regulatory CMC.

We are hiring two Process Engineers supporting the Downstream Tech Transfer group within MS&T.

Responsibilities

• 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.
• 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.

Required qualifications

• 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.