Principal Engineer - Global MSAT, Site , Redmond, WA

Job Title

Principal Process Engineer – Global MSAT

• 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, risk assessments and mitigation plans are performed and that design spaces (PAR & NOR ranges) for critical process parameters are built 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 documents or process control strategies for Phase
  
  III and commercial programs for receiving sites across the manufacturing network.
• Provide onsite support for new facility or client startup engineering runs and performance qualification runs, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections.
• May include direct reports and management of junior process engineers.

• Bachelor’s degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience 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 downstream process chromatography, continuous chromatography, large‑scale column packing, viral filtration, and tangential flow filtration, with additional knowledge of single‑use bioreactors and perfusion technology.
• Experienced in 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 providing oversight to continuous process monitoring strategies and maintaining process validation status throughout the commercial lifecycle.
• Apply manufacturing process lifecycle management principles to establish and continuously improve process control strategy.
• Experience 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, attention to detail, effective task/time‑management, and organizational skills.
• Strategic mindset, ability to organize, analyze, interpret, and effectively 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 from bench‑scale through commercial manufacturing scale.
• Expertise to solve complex technical problems and 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 in work approach, and strong follow‑through and accountability.

• Base salary range at commencement of employment: $155,000 to $172,000, with variation based on skills, experience and market value.
• Discretionary annual bonus.
• Comprehensive benefits package, including medical, dental and vision; short‑term and long‑term disability; company‑paid basic life insurance; 401(k) with company match.
• Flexible work options; generous paid time off and paid holidays.
• Wellness and transportation benefits.
• Global MSAT network alignment and access to cutting‑edge technology and training opportunities.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.