Principal Global MSAT Tech Transfer Lead

Evotec SE; Redmond (WA); Sur place; USD 155 000 - 172 000; Plein temps

Avantages offerts par ce poste

Discretionary bonus

Benefits package

Résumé du poste

Just Evotec Biologics in Redmond, WA, seeks a Principal Process Engineer to lead late-stage tech transfer for clinical and commercial biologics. You’ll drive cross-site projects, develop validated processes, and optimize transfer workflows across the manufacturing network.

The role requires deep expertise in downstream/upstream processing, regulatory CMC, and GMP. Mentoring junior engineers and contributing to regulatory submissions are key parts of this position.

Qualifications

• Over 10 years of experience in biopharma process engineering or a related field.
• Deep expertise in downstream processing and cell culture biopharmaceuticals.
• Proven track record leading technology transfer for late-stage or commercial programs.
• Strong knowledge of GMP concepts, QA, and regulatory CMC documentation.
• Experience with process validation, CPP/PPQ campaigns, and CTQ development.
• Statistical analysis skills and use of risk tools (FMEA) for process risk assessment.
• Experience with DeltaV automation and MES for manufacturing operations.
• Ability to mentor junior engineers and manage cross-site projects.

Responsabilités

• Project Lead for tech transfer of late-stage and commercial manufacturing campaigns.
• Coordinate site-to-site tech transfer activities and risk mitigation.
• Develop and implement process validation and continued verification strategies.
• Review and approve technical docs, PPQ protocols, batch records, and reports.
• Lead development of global templates and documentation for tech transfer and NPI.
• Analyze process data and perform periodic reviews across manufacturing sites.
• Create transfer documents and process control strategies for phase III and commercial programs.

Connaissances

Downstream processing

Cell culture

Tech transfer

Process validation

GMP knowledge

Statistical analysis

FMEA risk assessment

DeltaV automation

MES systems

Leadership/mentoring

Regulatory documentation

Formation

Bachelor's degree in engineering

MS in engineering

Outils

DeltaV

MES systems

Description du poste

Just Evotec Biologics in Redmond, WA, seeks a Principal Process Engineer to lead late-stage tech transfer for clinical and commercial biologics. You’ll drive cross-site projects, develop validated processes, and optimize transfer workflows across the manufacturing network.

The role requires deep expertise in downstream/upstream processing, regulatory CMC, and GMP. Mentoring junior engineers and contributing to regulatory submissions are key parts of this position.