Downstream Process Transfer Engineer III

Evotec SE; Redmond (WA); In loco; USD 92.000 - 127.000; Tempo pieno

Descrizione del lavoro

Just Evotec Biologics in Redmond, WA is seeking a Process Engineer III to join the Global MSAT Tech Transfer team. In this role you’ll drive downstream tech transfer, support late-stage and commercial manufacturing, and help build global templates and documentation to enable site-to-site transfers.

You’ll analyze process data, develop validation strategies, and author transfer documents while collaborating with site teams.

Competenze

• Experience supporting process transfer/tech transfer projects in biopharma.
• Knowledge of downstream processing and continuous chromatography.
• Familiar with risk assessment tools (FMEA) and process modeling.
• Strong GMP/QA understanding for tech transfer and validation.
• Hands-on experience with downstream disposable manufacturing tech.
• Strong communication and collaboration skills.

Mansioni

• Support downstream tech transfer of late-stage molecules and PPQ campaigns.
• Coordinate site-to-site tech transfer activities.
• Develop and review technical docs for qualifications and PPQ runs.
• Create templates for process validations and V&V strategies.
• Analyze process data including annual reviews across sites.
• Draft process transfer documents for phase III and commercial programs.
• Ensure gap analyses and mitigation plans for critical process parameters.

Conoscenze

Process transfer

Tech transfer

Downstream processing

GMP knowledge

Data analysis

Communication skills

Formazione

Bachelor’s degree in engineering or sciences

MS degree in related field

Strumenti

DeltaV

Descrizione del lavoro

Just Evotec Biologics in Redmond, WA is seeking a Process Engineer III to join the Global MSAT Tech Transfer team. In this role you’ll drive downstream tech transfer, support late-stage and commercial manufacturing, and help build global templates and documentation to enable site-to-site transfers.

You’ll analyze process data, develop validation strategies, and author transfer documents while collaborating with site teams.