Global Biotech Process Engineering Lead

Evotec SE; Redmond (WA); On-site; USD 134,000 - 154,000; Full time

Job summary

Just-Evotec Biologics in Redmond, WA is seeking a Principal Process Engineer to lead and shape the equipment, technologies, and single-use solutions used across the manufacturing network. You will drive technical leadership, collaborate with MSAT, Manufacturing, Automation, and external vendors to improve efficiency and throughput.

You will guide design, qualification, and GMP readiness from concept through testing, provide site support, and contribute to regulatory submissions and inspections.

Qualifications

• BS in engineering, sciences, or related life science engineering with 12+ years in pharma/biotech or MS with 10+ years.
• Deep knowledge of biopharmaceutical manufacturing processes and technologies (chromatography, filtration, viral clearance, formulation, upstream).
• Experience with single-use bioprocessing equipment and validation activities.
• Ability to lead technology implementations for clinical and commercial manufacturing readiness.
• Strong communication and cross-functional leadership skills.

Responsibilities

• Lead evaluation, design, development, and implementation of manufacturing technologies across the network.
• Develop lifecycle and maintenance programs for GMP equipment and technologies.
• Support evaluation and approval of innovative technologies via project governance.
• Collaborate with stakeholders and vendors to test and adopt technologies to increase throughput.
• Create global design documents (URS, FFS) based on process needs and validation protocols.
• Coordinate with Automation on DCS/PLC integration.
• Provide technical leadership for facility fit, utilities, layouts, and CQV activities.
• Advance single-use tech, instrumentation, manifolds, and assemblies for the platform.
• Develop data/validation packages to support GMP use; create SOPs and training.
• Build equipment maintenance and lifecycle plans for deployed assets.
• Partner with Site MSAT Manufacturing Technology & Science on global/site objectives.
• Provide SME support for Non-Conformance, CAPAs, and impact assessments.

Skills

Biopharma manufacturing

Leadership

Cross-functional collaboration

Process optimization

Quality systems

Education

BS in engineering or life sciences

MS in related field

Tools

DeltaV automation

DCS integration

PLC systems

Validation (CQV)

Job description

Just-Evotec Biologics in Redmond, WA is seeking a Principal Process Engineer to lead and shape the equipment, technologies, and single-use solutions used across the manufacturing network. You will drive technical leadership, collaborate with MSAT, Manufacturing, Automation, and external vendors to improve efficiency and throughput.

You will guide design, qualification, and GMP readiness from concept through testing, provide site support, and contribute to regulatory submissions and inspections.