Principal Process Engineer - Site , Redmond, WA

Responsibilities

• Provide project leadership for late-stage molecule process transfer/tech transfer for clinical and commercial biologics manufacturing.
• Lead site-to-site tech transfer activities.
• Perform gap analysis/risks assessments; ensure mitigation plans are in place.
• Build design spaces (PAR & NOR ranges) for critical process parameters to support validation and late-stage/commercial manufacturing.
• Support development, review, and approval of technical documentation (global performance qualification protocols, batch records, and engineering/GMP/PPQ run reports).
• Develop and implement templates for Process Validations and Continued Process Verification strategies.
• Lead analysis of process data, including annual periodic reviews across the manufacturing site network.
• Develop process transfer documents and/or process control strategy for Phase III and commercial programs for receiving sites.
• Support network alignment strategy implementation and creation of global tech transfer/new product introduction templates/documentation across the manufacturing network.
• Provide onsite support for new facility/client startup engineering runs and performance qualification runs.
• Assist generation of regulatory submissions; support regulatory and site inspections.
• May manage direct reports/junior process engineers.

• Bachelor’s degree in engineering science or related field with 12+ years relevant experience, or 8+ years with an MS.
• Subject matter expertise in downstream processing (chromatography, continuous chromatography, large-scale column packing, viral filtration, tangential flow filtration) and knowledge of single-use bioreactors and perfusion technology.
• Subject matter expertise in cell culture biopharmaceutical manufacturing/development (perfusion technologies, single-use bioreactor operations, scale-up strategies).
• Experience leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial PPQ campaigns.
• Understanding of GMP concepts and quality systems for process transfer and validation.
• Experience with continuous process monitoring strategies and process validation status across the commercial lifecycle.
• Ability to apply manufacturing process lifecycle management principles to establish and improve process control strategies.
• Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and supporting inspections.
• 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 quality focus, attention to detail, and task/time management.
• Strategic mindset; ability to translate downstream expertise into global procedures/templates.
• Demonstrated skill managing and mentoring direct reports.

• Technical mastery of upstream or downstream operations and continuous processing from bench-scale through commercial scale.
• Ability to solve complex technical problems; apply novel approaches.
• Experience leading technical projects with external collaborators and vendors.
• Ability to navigate global regulatory CMC documents.
• High initiative, flexibility, follow-through, and accountability.