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

Evotec WD; Redmond (WA); On-site; USD 155,000 - 172,000; Full time

Job summary

Evotec is seeking a Principal Process Engineer to lead late-stage molecule tech transfer and PPQ campaigns across a global MSAT network. You will drive site-to-site tech transfer, develop robust validation and process control strategies, and oversee global documentation for GMP/commercial programs.

The role requires deep expertise in downstream/upstream processing, process validation, and regulatory CMC activities, with a track record of mentoring junior engineers and delivering cross-site

Qualifications

• Bachelor's degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience with an MS.
• Subject matter expert in downstream processing including continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration; knowledgeable in single-use bioreactors and perfusion technology.
• Subject matter expert in cell culture biopharmaceutical manufacturing or development of cell culture processes including perfusion technologies, single use bioreactor operations, and scale-up strategies (Upstream).
• Experienced in leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial PPQ campaigns/ campaigns.
• Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
• Experience developing oversight to continuous process monitoring strategies and process validation status throughout commercial lifecycle.
• Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
• Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
• Solid background in statistical analysis.
• Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments.
• Working knowledge of manufacturing process equipment, DeltaV automation systems, and MES.
• Candidate must possess strong focus on quality and attention to detail as well as effective task/time management.
• Strategic mindset, ability to organize, analyze/interpret, and translate downstream expertise into global procedures/templates.
• Demonstrated skill managing and mentoring direct reports.

Responsibilities

• Project Lead for technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support.
• Lead site to site Tech Transfer activities.
• Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
• Support development, review and approval of technical documentation including global protocols for performance qualifications, batch records, and reports related to engineering, GMP and PPQ runs.
• Lead the development and implementation templates for Process Validations and Continued Process Verification strategies.
• Lead the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
• Develop Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the MFG network.

Skills

Downstream processing

Continuous chromatography

Viral filtration

Tangential flow filtration

Single-use bioreactors

Perfusion technology

Upstream processes

Process transfer

Process validation

GMP compliance

CMC documentation

Statistical analysis

FMEA

DeltaV automation

Manufacturing Execution Systems

Leadership

Mentoring

Education

Bachelor's degree

MS preferred

Tools

DeltaV automation

MES

Global MSAT tools

Job description

Job Title: Principal Process Engineer

About Us

this is who we are At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCurious with us and see where your curiosity can take you!

The Role

We're looking for a passionate and curious Principal Process Engineer to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you will have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a Principal Process Engineer at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. Just is seeking a highly motivated Principal Process Engineer in Global MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to provide project leadership for late-stage molecule process transfer / tech transfer for clinical and commercial biologics manufacturing, including the support for development and maintenance of technical documentation for process control and validation strategies. The selected candidate as part of the Global MSAT Tech Transfer team is responsible for supporting the implementation of network alignment strategy and creation of global templates/documentation for Tech transfer/New Product introduction across JUST Evotec Manufacturing network. The team member will also provide onsite support for new facility or client startup engineering runs and performance qualification runs, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections. This role may also include direct reports/management of junior process engineers.

What You'll Do

• Project Lead for technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support.
• Lead site to site Tech Transfer activities.
• Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
• Support development, review and approval of technical documentation including global protocols for performance qualifications, batch records, and reports related to engineering, GMP and PPQ runs.
• Lead the development and implementation templates for Process Validations and Continued Process Verification strategies.
• Lead the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
• Develop Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the MFG network.

Who You Are

• Bachelor's degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience with an MS.
• Considered a subject matter expert in downstream processing, including downstream process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration, but also knowledgeable in single-use bioreactors and perfusion technology.
• Considered a subject matter expert in cell culture biopharmaceutical manufacturing and or development of cell culture processes including perfusion technologies, single use bioreactor operations, and scale-up strategies (Upstream).
• Experienced in leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial qualification PPQ campaigns/ commercial campaign support.
• Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
• Experience developing and providing oversight to continuous process monitoring strategies and process validation status throughout commercial lifecycle.
• Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
• Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
• Solid background in statistical analysis.
• Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments.
• Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems.
• Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
• Strategic mindset, ability to organize, analyze/interpret, and effectively translate downstream expertise into global procedures/templates.
• Demonstrated skill managing and mentoring direct reports.

Additional Preferred Qualifications

• Recognized technical mastery of either upstream or downstream operations and continuous processing bench-scale through commercial manufacturing scale.
• Knowledge and expertise to solve complex technical problems; may apply novel approaches that provides significant technology advancement.
• Experience leading technical projects with external collaborators and vendors.
• Ability to navigate global regulatory CMC documents.
• High level of demonstrated initiative, exhibit flexibility in work approach, and demonstrate strong follow through and accountability.

Why Join Us

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This role is site based.
• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.

The base pay range for this position at commencement of employment is expected to be $155k-$172; this is a salary exempt role.

Base salary offered may vary depending on the individual’s skills, experience and competitive market value.

Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, 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.

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this Data-driven R&D Autobahn to Cures for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence.

For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.