Global MSAT Process Engineering Leader

Evotec WD; Redmond (WA); On-site; USD 155,000 - 172,000; Full time

Benefits offered by this job

Flexible work options

Growth opportunities

Inclusive culture

Wellness benefits

Job summary

Just Evotec Biologics seeks a Principal Process Engineer to lead late-stage technology transfer and PPQ campaigns across a global manufacturing network. You will guide cross-site teams, develop process control strategies, and ensure GMP compliance throughout clinical to commercial programs.

The role involves authoring regulatory documents, coordinating with quality systems, and supporting regulatory inspections. Significant expertise in downstream processing and continuous improvement is crucial.

Qualifications

• Bachelor’s degree in engineering or related field with substantial experience in biopharma processing.
• Subject matter expert in downstream processing and/or upstream with scale-up experience.
• Experience leading tech transfer and PPQ campaigns for late-stage clinical or commercial products.
• Ability to author regulatory CMC documents and support health authority interactions.

Responsibilities

• Project Lead for technology transfer of late-stage molecule to commercial manufacturing.
• Lead site-to-site tech transfer activities with risk analyses and mitigation plans.
• Develop and validate process control strategies for phase III and commercial programs.
• Prepare regulatory documentation and support for inspections.

Skills

Downstream processing

Cell culture biopharmaceuticals

Technology transfer

Process validation

GMP/compliance

Statistical analysis

Risk assessment (FMEA)

DeltaV automation

MES / manufacturing systems

Education

Bachelor’s degree in engineering

MS in engineering (preferred)

Tools

DeltaV

Manufacturing Execution Systems

Job description

Just Evotec Biologics seeks a Principal Process Engineer to lead late-stage technology transfer and PPQ campaigns across a global manufacturing network. You will guide cross-site teams, develop process control strategies, and ensure GMP compliance throughout clinical to commercial programs.

The role involves authoring regulatory documents, coordinating with quality systems, and supporting regulatory inspections. Significant expertise in downstream processing and continuous improvement is crucial.