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

Evotec; Redmond; On-site; AUD 222,000 - 246,000; Full time

Benefits offered by this job

Growth opportunities

Flexible work options

Inclusive culture

Innovative projects

Big ideas culture

Job summary

Just Evotec Biologics seeks a Principal Process Engineer to drive late-stage tech transfer for clinical and commercial biologics, leading cross-site efforts in the Global MSAT team. You will develop and maintain documentation, support regulatory submissions, and mentor junior engineers while advancing process control strategies.

You will oversee tech transfer activities, perform risk assessments, and contribute to process validation plans across multiple sites, ensuring GMP compliance and

Qualifications

• Bachelor's degree in engineering with 12+ years' experience (or MS with 8+ years of relevant experience).
• Subject matter expert in downstream processing (continuous chromatography, large-scale packing, viral filtration, tangential flow filtration).
• Subject matter expert in cell culture biopharmaceutical manufacturing and scale-up strategies.
• Experience leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial campaigns.
• Understanding of GMP concepts and quality systems for process transfer and validation activities.
• Experience developing continuous process monitoring strategies and CPPV status throughout commercial lifecycle.
• Authoring regulatory CMC documents and coordinating responses to health authority questions.
• Strong background in statistics.
• Experience with process risk assessment tools (FMEA).
• Knowledge of DeltaV automation systems and MES.

Responsibilities

• Lead technology transfer for late-stage molecule/PPQ campaigns.
• Coordinate site-to-site tech transfer activities across the network.
• Develop templates for process validations and continued process verification strategies.
• Lead analysis of process data across the network of manufacturing sites.
• Support regulatory submissions and inspections.

Skills

Downstream processing

Cell culture

Tech transfer

Process validation

GMP compliance

Statistical analysis

Risk assessment

DeltaV automation

MES

Project leadership

Education

Bachelor's degree in engineering

MS in engineering

Tools

DeltaV automation

MES

Job description

Job Title: Principal Process Engineer

About Us

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!

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'll 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. (Downstream)
• 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.

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? We can't wait to see where your curiosity leads you- and how it will shape the future of Just Evotec Biologics. Let your curiosity guide your career-#BeCurious and explore the endless possibilities at Just Evotec Biologics!

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.