Principal Engineer - Global MSAT, Site based, Redmond, WA

Principal Process Engineer – Global MSAT Just Evotec Biologics is dedicated to creating innovative solutions to improve access to biotherapeutics. The Principal Process Engineer will provide project leadership for technology transfer of late‑stage molecules and commercial manufacturing, overseeing technical documentation, validation strategies, and regulatory support across our manufacturing network. The Role As a member of the Global MSAT Tech Transfer team, you will support the implementation of network alignment strategy, develop global templates, provide onsite support for new facilities or client starts, assist with regulatory submissions, and potentially manage junior process engineers. Responsibilities Lead technology transfer of late‑stage molecules/commercial manufacturing and PPQ campaign support. Lead site‑to‑site tech transfer activities and conduct gap analysis, risk assessments, and mitigation plans. Design and build critical process parameter ranges (PAR & NOR) for validation and late‑stage/commercial operations. Support development, review, and approval of technical documentation, including global protocols for performance qualifications, batch records, and reports. Develop and implement templates for process validations and continued process verification strategies. Analyze process data, conduct annual periodic reviews across manufacturing sites. Develop process transfer documents or control strategies for phase III and commercial programs. Qualifications Bachelor’s degree in engineering science or related program; 12+ years of experience or 8+ years with an MS. Subject‑matter expert in cell‑culture biopharmaceutical manufacturing, including perfusion technologies, single‑use bioreactor operations, and scale‑up (upstream). Subject‑matter expert in downstream processing: chromatography, continuous chromatography, large‑scale column packing, viral filtration, tangential flow filtration, single‑use bioreactors, and perfusion. Experience leading technology transfer and process validation for late‑stage clinical manufacturing and commercial qualification PPQ campaigns. Understanding of GMP concepts and quality systems for process transfer and validation. Experience with continuous process monitoring strategies and process validation status throughout commercial lifecycle. Apply manufacturing process lifecycle management principles to establish and improve process control strategy. Author regulatory CMC documents, coordinate responses to health‑authority questions, and provide inspection support. Solid background in statistical analysis and risk assessment tools such as FMEA. Working knowledge of manufacturing equipment, DeltaV automation, and MX systems. Strong focus on quality, attention to detail, effective task/time management, and organizational skills. Strategic mindset; able to translate upstream expertise into global procedures/templates. Demonstrated skill managing and mentoring direct reports. Preferred Qualifications Technical mastery of upstream or downstream operations and continuous processing from bench‑scale to commercial manufacturing. Ability to solve complex technical problems with novel approaches. Experience leading technical projects with external collaborators and vendors. Navigation of global regulatory CMC documents. High level of initiative, flexibility, follow‑through, and accountability. Benefits Growth opportunities with professional courses, mentorship, and new projects. Flexible site‑based work environment. Diverse and inclusive culture. Opportunities to work on groundbreaking initiatives. The base pay range for this position at commencement of employment is expected to be $155,000 to $172,000; additional total rewards include discretionary annual bonus, comprehensive benefits (medical, dental, vision, short‑ and long‑term disability, company‑paid basic life insurance, 401(k) company match), flexible work, paid time off, paid holidays, wellness, and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status. #J-18808-Ljbffr Just - Evotec Biologics