Principal Process Engineer - Site Based, Redmond, WA
Evotec
5 months ago
On-site
Redmond, WA
Operations
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.
Qualifications:
- 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, DeltaV 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.
Preferred qualifications:
- 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.
Application instructions:
- Apply today.
- 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.
Qualifications:
- 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, DeltaV 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.
Preferred qualifications:
- 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.
Application instructions:
- Apply today.