Process Engineer III - Biotech Manufacturing Innovator

Evotec SE; Redmond (WA); On-site; USD 92,000 - 127,000; Full time

Job summary

Just-Evotec Biologics is seeking a Process Engineer III in Redmond, WA to lead the design, development and deployment of new equipment and technologies across the manufacturing network.

You will collaborate with MSAT, manufacturing operations, and vendors to evaluate technologies, develop documents, support validation, and prepare regulatory submissions; strong cGMP knowledge and experience with single-use systems are essential.

Qualifications

• BS in engineering or life sciences with 5+ years in pharma/biotech or MS with 2+ years
• Subject matter expert in single-use processing equipment and technologies
• Experience leading technology implementation and validation activities for clinical and commercial manufacturing
• Working knowledge of cGMP regulations for biologics/pharmaceuticals
• Understanding monoclonal antibody processing at manufacturing scale
• Experience with single-use disposable systems
• Strong communication and cross-functional collaboration
• Ability to organize, analyze and interpret process data

Responsibilities

• Evaluate new technologies with stakeholders to improve throughput
• Develop design documents based on platform requirements and CQV protocols
• Collaborate with automation on DCS design for manufacturing suite
• Lead technology evaluation of single-use systems
• Develop data and validation packages with vendors
• Facilitate procurement and implementation of new tech
• Develop SOPs and training for equipment and technologies
• Lead maintenance and lifecycle planning
• Lead non-conformance investigations and assess process impact
• Support audits/inspections and regulatory submissions

Skills

Single-use systems

cGMP knowledge

Biopharma manufacturing

Cross-functional teamwork

Process data analysis

Education

BS in engineering or related life sciences

MS in engineering or related life sciences

Tools

DeltaV automation

Job description

Just-Evotec Biologics is seeking a Process Engineer III in Redmond, WA to lead the design, development and deployment of new equipment and technologies across the manufacturing network.

You will collaborate with MSAT, manufacturing operations, and vendors to evaluate technologies, develop documents, support validation, and prepare regulatory submissions; strong cGMP knowledge and experience with single-use systems are essential.