Principal Process Engineer, MSAT

Evotec WD; 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 cross-functional MSAT projects across the manufacturing network. You will shape equipment, technologies, and single-use solutions, partnering with MSAT, Manufacturing, Automation, and external vendors to drive efficiency, reliability, and throughput.

This role spans concept through GMP readiness and regulatory support. The successful candidate will bring 12+ years of relevant experience, strong biotech process

Qualifications

• BS or MS in engineering or life sciences; 10+ years experience for MS or 12+ years for BS.
• Strong knowledge of biopharmaceutical manufacturing processes and technologies (e.g., chromatography, filtration).
• Experience with single-use bioprocessing equipment and CQV activities.

Responsibilities

• Lead evaluation, design, development, and implementation of new manufacturing technologies across the network.
• Develop lifecycle and maintenance programs for GMP equipment and technologies.
• Support evaluation and approval of innovative technologies within the platform via governance groups.
• Collaborate with stakeholders to test and implement technologies to boost efficiency and throughput.
• Create global design documents (URSpec, FDS) based on platform requirements and validation plans.
• Work with Automation on DCS design and PLC integration for manufacturing equipment.
• Lead site CQV activities and provide technical leadership for facility readiness.

Skills

Chromatography

Filtration

Viral clearance

Single-use equipment

Education

BS in engineering or life sciences

MS in engineering

Tools

DeltaV automation

PLC integration

Job description

Job title: Principal Process Engineer Location: Redmond, WA Reports to: Director, Technical Operations

About Us: 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? #BeCureious with us and see where your curiosity can take you! #BeCurious with us and see where your curiosity can take you!

The Role

As a Principal Process Engineer on our Global MSAT Process Engineering team, you’ll play a leading role in shaping the equipment, technologies, and single-use solutions used across the Just-Evotec Biologics manufacturing network. This position provides an opportunity to operate as a technical leader and subject matter expert, partnering across MSAT, Manufacturing, Automation, Engineering, and external technology vendors to evaluate, develop, and implement innovative solutions that improve manufacturing efficiency, reliability, and facility throughput. You’ll lead cross-functional technology evaluations, develop global design and implementation strategies, and help advance new technologies from concept and testing through qualification and GMP manufacturing readiness. You’ll also provide technical and operational support to Site MSAT and Manufacturing Operations teams across the network. The role will provide in-plant support, contribute to regulatory submission documentation, and support regulatory and site inspections.

What You’ll Do

• Lead the evaluation, design, development, and implementation of new and existing manufacturing technologies across the Just-Evotec Biologics manufacturing network.
• Develop the lifecycle and maintenance management program for GMP equipment and technologies.
• Support the evaluation and approval of innovative technologies within the manufacturing platform through the project governance group.
• Work with key stakeholders and vendors to evaluate innovative technologies for implantation into the manufacturing process to increase efficiency and facility throughput.
• Work with cross functional teams on the development of global design documents (user requirement specifications, software functional specifications) based on platform process requirements and validation commissioning and qualification protocols.
• Collaborate with Automation on the design and development of Distributed Control Systems (DCS) and integration of PLC-based equipment.
• Provide technical leadership for facility fit assessments, utility requirements, equipment layouts, and associated Commissioning, Qualification, and Validation (CQV) activities.
• Evaluate and advance single-use technologies, instrumentation, manifolds, and assemblies for use within the manufacturing platform.
• Work with vendors to test and develop equipment/technologies and develop the required data and validation packages to support these technologies in a GMP environment.
• Develop business processes, guidelines, SOPs (Standard Operating Procedures), and training for processing equipment and technologies.
• Build the equipment maintenance & life cycle plans to support the equipment deployed in the manufacturing network.
• Partner with Site MSAT Manufacturing Technology & Science teams on global and site objectives.
• Provide subject matter expert support in Non-Conformance investigation, CAPAs and provide process impact evaluations of equipment issues.

Who You Are

• BS in engineering, sciences, or related life science engineering 12+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 10+ years of experience.
• Demonstrated technical expertise in biopharmaceutical manufacturing processes and technologies, with strong knowledge of one or more areas such as chromatography, filtration, viral clearance, drug substance formulation, or upstream processing.
• Understanding of upstream cell culture expansion and processing operations, including perfusion processing.
• Significant experience with single-use bioprocessing equipment, technologies, instrumentation, and/or assemblies.
• Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness.
• Experience executing facility fit assessments and process validation activities.
• Demonstrated ability to work independently and lead collaborative cross-functional teams.
• Candidate must focus on quality, attention to detail, and effective task/time management organizational skills.
• Ability to organize, analyze/interpret, and present data and project updates to effectively information senior leadership.

Additional Preferred Qualifications

• Experience with upstream processing, including cell culture expansion and/or perfusion processing.
• Experience with DeltaV automation and the integration of PLC-based and non-PLC-based manufacturing equipment.
• Participation in global teams, Center of Excellence, etc.
• Applies knowledge and expertise to solve complex technical problems.
• Experience developing and executing CQV plans and protocols.
• Can work independently and in project teams; May lead cross functional projects at Just-Evotec utilizing functional area expertise.

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.

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.

Are You Still Curious?

If you’ve read this far, then chances are you’ve got a curious mind, just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you and how it will shape the future of Just-Evotec. Let your curiosity guide your career #BeCurious and explore the endless possibilities at Just-Evotec! The base pay range for this position at commencement of employment is expected to be $134,000 to $154,100; Base salary offered may vary depending on 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, flexible work, 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.