Principal Process Engineer

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

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!

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.

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.