Principal Engineer - Global MSAT, Site , Redmond, WA

Overview

Job Title: Principal Process Engineer – Global MSAT

Just Evotec Biologics is seeking a highly motivated Principal Process Engineer in the Global MSAT team to drive late-stage molecule process transfer and tech transfer for clinical and commercial biologics manufacturing, and to support development and maintenance of technical documentation for process control and validation strategies.

• 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 of 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 documentation and/or process control strategy for Phase III and commercial programs for receiving sites across the manufacturing network.

• Bachelor’s degree in engineering or related field with 12+ years of relevant experience, or 8+ years with an MS.
• 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).
• Subject matter expert in downstream processing, including chromatography (continuous chromatography), large-scale column packing, viral filtration, and tangential flow filtration; knowledge of single-use bioreactors and perfusion technology (Downstream).
• Experience 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 overseeing continuous process monitoring strategies and process validation status throughout the 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.
• 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.
• Strong focus on quality and attention to detail, with effective task and time management skills.
• Strategic mindset with ability to organize, analyze, and translate upstream expertise into global procedures/templates.
• Demonstrated skill in managing and mentoring direct reports.

• Recognized technical mastery of either upstream or downstream operations and continuous processing bench-scale through commercial manufacturing scale.
• Ability to solve complex technical problems; may apply novel approaches that provide significant technology advancement.
• Experience leading technical projects with external collaborators and vendors.
• Ability to navigate global regulatory CMC documents.
• High level of initiative, flexibility, follow-through and accountability.

• Growth Opportunities:
  We support continuous learning and development through courses, mentorship, or new projects.
• Flexible Work Environment:
  Site-based role with options to balance professional and personal life.
• Inclusive Culture: A diverse and inclusive environment where curiosity is encouraged.
• Innovative Projects:
  Work on groundbreaking initiatives…