Principal Process Engineer - Site , Redmond, WA

Principal Process Engineer

Just Evotec Biologics is a forward‑thinking team that thrives on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We believe curiosity is the spark that drives innovation and success.

As a Principal Process Engineer in the Global MSAT team, you will provide project leadership for late‑stage molecule process transfer and technology transfer for clinical and commercial biologics manufacturing, support the development and maintenance of technical documentation, and offer onsite support for new facility or client startup engineering runs. This role may include direct reports and management of junior process engineers.

• Project Lead for technology transfer of a Late‑Stage molecule, commercial manufacturing and/or PPQ campaign support.
• Lead site‑to‑site Tech Transfer activities.
• Ensure gap analysis/risks assessments are performed and mitigation plans are in place, and that design spaces (PAR & NOR ranges) support validation 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 of templates for Process Validations and Continued Process Verification strategies.
• Lead the analysis of process data across the network of Manufacturing sites and perform annual periodic reviews.
• Develop Process transfer documents and process control strategies for Phase III and commercial programs for receiving sites across the MFG network.

• Bachelor’s degree in engineering science or related program with 12+ years relevant experience, or 8+ years with an MS.
• Subject matter expert in downstream processing (chromatography, continuous chromatography, large‑scale column packing, viral filtration, tangential flow filtration, single‑use bioreactors and perfusion technology).
• Subject matter expert in cell culture biopharmaceutical manufacturing or development of cell culture processes (perfusion technologies, single‑use bioreactor operations, scale‑up strategies).
• Experienced in leading technology transfer and process validation activities for late‑stage clinical manufacturing and commercial qualification PPQ campaigns.
• Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
• Experience in continuous process monitoring strategies and process validation status throughout commercial lifecycle.
• Apply manufacturing process lifecycle management principles to establish and continuously improve process control strategy.
• 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, Delta
  
  V automation systems, and Manufacturing Execution Systems.
• Strong focus on quality and attention to detail, effective task/time management, and organizational skills.
• Strategic mindset with ability to organize, analyze/interpret, and translate downstream expertise into global procedures/templates.
• Demonstrated skill managing and mentoring direct reports.

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

• Growth Opportunities: professional courses, mentorship, and new projects to support continuous learning and development.
• Flexible Work Environment: this role is site‑based but offers flexibility to balance professional and personal life.
• Inclus…