Principal Engineer – Global MSAT

Jobtailor; Redmond (WA); On-site; USD 180,000 - 230,000; Full time

Job summary

Jobtailor seeks an experienced engineer to lead late-stage molecule process transfer and technology transfer for clinical and commercial biologics manufacturing. You will develop and maintain technical documentation for process control and validation, and support global standardization across the manufacturing network.

The role requires extensive expertise in downstream processing, viral filtration, and filtration technologies, with strong GMP knowledge, and a track record mentoring engineers.

Qualifications

• Requires 12+ years engineering experience, or 8+ years with an MS.
• Experience in downstream processing including chromatography, viral filtration, and tangential flow filtration.
• Experience leading technology transfer and PPQ campaigns for late-stage clinical and commercial programs.
• Strong GMP understanding and quality systems knowledge.
• Ability to mentor junior engineers and lead cross-site teams.

Responsibilities

• Provide project leadership for late-stage molecule process transfer and technology transfer across clinical and commercial biologics manufacturing.
• Support development and maintenance of documentation for process control and validation strategies.
• Lead creation of global templates and documentation for transfer and new product introduction.
• Provide onsite support for facility startups and performance qualification runs.
• Lead development and implementation of templates for process validations and continued process verification.

Skills

Downstream Processing

Technology Transfer Leadership

Regulatory CMC Writing

Process Validation

GMP Knowledge

Statistical Analysis

Mentoring

Problem-Solving

Education

Bachelor’s degree in Engineering

MS in Engineering

Tools

DeltaV Automation Systems

Manufacturing Execution Systems

Process Data Analysis Tools

Job description

• Provide project leadership for late-stage molecule process transfer/technology transfer for clinical and commercial biologics manufacturing
• Support development and maintenance of technical documentation for process control and validation strategies
• Support implementation of network alignment strategy
• Create global templates and documentation for technology transfer and new product introduction across the manufacturing network
• Provide onsite support for new facility or client startup engineering runs and performance qualification runs
• Assist in generating relevant regulatory submissions
• Support regulatory and site inspections
• Manage or provide direct reports/management of junior process engineers
• Lead site-to-site technology transfer activities
• Lead gap analyses and risk assessments, establish mitigation plans, and build design spaces for critical process parameters
• Support development, review, and approval of technical documentation, including global performance qualification protocols, batch records, and engineering/GMP/PPQ reports
• Lead development and implementation of templates for process validations and continued process verification strategies
• Lead process data analysis, including annual periodic reviews across manufacturing sites
• Develop process transfer documents and process control strategies for Phase III and commercial programs at receiving sites

Requirements

• 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 expertise in downstream processing, including downstream process chromatography, continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration
• Knowledge of single-use bioreactors and perfusion technology
• Subject matter expertise in cell culture biopharmaceutical manufacturing or development of cell culture processes, including perfusion technologies, single-use bioreactor operations, and scale-up strategies
• 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
• Experience developing and overseeing continuous process monitoring strategies and process validation status throughout the commercial lifecycle
• Knowledge of manufacturing process lifecycle management principles
• 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 such as 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
• Effective task/time management and organizational skills
• 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 through commercial manufacturing scale
• Knowledge and expertise to solve complex technical problems and apply novel approaches
• Experience leading technical projects with external collaborators and vendors
• Ability to navigate global regulatory CMC documents
• Demonstrated initiative, flexibility, follow-through, and accountability

Core Competencies

Demonstrates expertise in downstream processing and technology transfer for clinical and commercial biologics manufacturing, with a strong focus on regulatory compliance and process validation. Proven ability to lead projects, mentor teams, and develop technical documentation to support manufacturing operations.

Highest-signal resume keywords

• Downstream Processing Expertise
• Technology Transfer Leadership
• Regulatory CMC Document Authoring
• Process Validation Experience
• GMP Knowledge

Hard Skills

• Downstream Process Chromatography
• Continuous Chromatography
• Large Scale Column Packing
• Viral Filtration
• Tangential Flow Filtration
• Single-Use Bioreactor Operations
• Process Risk Assessment Tools
• Statistical Analysis
• Process Control Strategies
• Process Validation Status Management

Soft Skills

• Effective Task Management
• Organizational Skills
• Mentoring Skills
• Attention to Detail
• Problem-Solving Skills

Industry Keywords

• Biologics Manufacturing
• GMP Concepts
• Regulatory Submissions
• Process Lifecycle Management
• Commercial Qualification

Tools & Technologies

• DeltaV Automation Systems
• Manufacturing Execution Systems
• Continuous Process Monitoring Strategies