Process Engineer III - Site Based, Redmond, WA

Evotec • Redmond, WA

1d • $92,400 - $126,500 • Onsite

About The Position

Just Evotec Biologics is seeking a Process Engineer III for its Global MSAT team. The role supports technology-transfer leads in implementing network-alignment strategies and creating global templates and documentation for technology transfer and new product introduction across Just Evotec. Its primary focus is site-to-site technology transfer for late-stage clinical and commercial biologics across the manufacturing network. The position may also provide person-in-plant support, assist with regulatory submissions, and support regulatory and site inspections.

The engineer supports technology transfer and manufacturing or PPQ campaigns, assesses process gaps and risks, develops mitigation plans, and establishes design-space ranges for critical process parameters. The role also develops and reviews technical documentation, creates process validation and continued process verification templates, analyzes process data across manufacturing sites, and authors process-transfer documents or process-control strategies for Phase III and commercial programs.

This is a site-based, salary-exempt role in Redmond, Washington, with a Monday-to-Friday day schedule. The expected base pay range at commencement is $92,400 to $126,500, with the actual offer varying according to skills, experience, and market value.

Requirements

• Bachelor’s degree in engineering, sciences, or a related program, with at least 5 years of relevant experience; alternatively, an MS degree with 2 years of experience.
• Experience supporting process-transfer or technology-transfer projects and teams in the biopharmaceutical industry.
• Familiarity with process-risk-assessment tools such as FMEA, process-model development, and process trending.
• Solid understanding of upstream processing, including single-use bioreactor operations and perfusion technology, at manufacturing scale or in biologics process development.
• Solid understanding of downstream processing, including process chromatography, continuous chromatography, large-scale column packing, viral filtration, and tangential-flow filtration, at manufacturing scale or in biologics process development.
• Solid understanding of GMP concepts and quality systems needed to support technology transfer and process validation.
• Hands-on experience with disposable-based manufacturing technologies from bench scale through commercial scale.
• Working knowledge of manufacturing-process equipment and automation systems.
• Strong focus on quality and attention to detail, with effective task, time-management, and organizational skills.
• Ability to organize, analyze, interpret, and communicate process data effectively.
• Strong interpersonal, teamwork, and collaboration skills.
• Excellent oral and written communication skills.

Nice To Haves

• Commercial manufacturing campaign-support experience.
• Practical experience or knowledge of upstream or downstream processing and disposable manufacturing technologies at manufacturing or bench scale.
• Ability to apply knowledge to solve complex technical problems.
• Ability to serve as a technical resource for upstream or downstream manufacturing processes and platforms.
• Ability to work independently and in project teams, and to lead projects within the functional area of expertise.
• Ability to navigate global regulatory CMC documents.
• Experience supporting late-stage manufacturing, technology transfer, and/or process-validation studies.
• Experience with DeltaV for process control.

Responsibilities

• Support technology transfer of late-stage molecules and commercial manufacturing, including PPQ campaign support.
• Support site-to-site technology-transfer activities across the manufacturing network.
• Perform or support gap analyses and risk assessments, establish mitigation plans, and build design-space ranges (PAR and NOR) for critical process parameters supporting validation and late-stage or commercial manufacturing.
• Develop, review, and approve technical documentation, including global performance-qualification protocols, batch records, and reports for engineering, GMP, and PPQ runs.
• Author templates for process validation and continued process verification strategies.
• Analyze process data, including annual periodic reviews across the manufacturing-site network.
• Author process-transfer documents and/or process-control strategies for Phase III and commercial programs at receiving sites.
• Provide person-in-plant support and assist with regulatory submissions and regulatory or site inspections as needed.

Benefits

• Professional courses, mentorship, and new-project opportunities for growth and development.
• Flexible work options.
• Medical, dental, and vision coverage.
• Short-term and long-term disability coverage.
• Company-paid basic life insurance.
• 401(k) company match.
• Generous paid time off and paid holidays.
• Wellness and transportation benefits.
• Discretionary annual bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level