Process Engineer III, Upstream –MSAT, Site Based, Redmond, WA

Role Summary

Process Engineer III, Upstream –MSAT, Site Based, Redmond, WA. Site-based role with travel to Seattle, WA; primarily Redmond site with some travel requirements.

Responsibilities

• Promotes a culture of safety
• Represents site MSAT on internal and external project teams as technical subject matter expert (SME) and interfaces with global MSAT, Manufacturing Operations and Quality functions
• Authors, reviews and approves GMP process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)
• Leads complicated and multi-disciplinary change controls and will function as a lead for the project team
• Partners with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions
• Utilizes technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation; drive implementation of CAPAs from approval to closure & effectiveness check
• Leads quality and technical risk assessment activities
• Supports and/or leads technology transfer or new production introduction activities
• Provides training and technical knowledge sharing to manufacturing
• Partners with Validation and Quality groups in supporting equipment onboarding activities and periodic review programs as process owners
• Supports on-call rotation to support 24/7 operations
• Acts as subject matter expert for regulatory and client inspection audits
• Applies Operational Excellence principles to lead continuous improvement ideas for manufacturing and technology transfer related activities

Qualifications

• Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience including a minimum of 2+ years of supporting upstream cell culture activities for biopharmaceutical products
• Knowledge and experience with CMC stage gates for clinical and commercial biologics drug substance manufacturing programs
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology
• Strong understanding of upstream processing including hands-on experience in single-use bioreactor operations and perfusion technology
• Solid understanding of GMP concepts and quality systems necessary to support manufacturing and new production introduction activities
• Working knowledge of manufacturing process equipment and automation systems
• Experience as deviation investigator and knowledge of root cause analysis tools (RCA)
• Strong focus on quality and attention to detail with effective task/time management
• Ability to organize, analyze/interpret, and effectively communicate process data
• Ability to work with high-performing teams, drive change, and influence stakeholders
• Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines applicable to drug substance biological manufacturing

Skills

• Upstream processing knowledge; single-use bioreactors; perfusion technology
• Process documentation and GMP compliance
• Quality systems, CAPA, change control, technology transfer
• Regulatory inspection readiness and audits
• Data analysis and process optimization

Education

• Masters or Bachelors in Engineering

Additional Requirements

• Experience in supporting audits and inspections by health authorities, clients, and external auditors
• Experience in risk assessment and risk management; Knowledge of Quality by Design
• Entrepreneurial drive; Delta V process control experience
• Experience with late-stage manufacturing, technical transfer and process validation studies