Staff Engineer, Process Systems

Senior Process Systems Engineer supporting biologics manufacturing at Vaxcyte, focusing on process systems for commercial launch and GMP operations.

• lead engineering activities for utilities, process equipment, automation, and facilities
• manage validation, oversee system inspections (FATs, IQ/OQ/PQ)
• drive project management from conception through completion, collaborating with cross-functional teams and CDMOs
• ensure regulatory compliance with FDA, EMA, and global standards
• provide strategic leadership for continuous improvement and technical excellence

• Bachelor's or Master’s in Engineering or Biotechnology
• 10+ years in bioprocessing or biotech/pharma industry
• proven leadership managing large-scale Cap Ex projects, utilities, and automation systems
• deep expertise in biopharmaceutical manufacturing, process validation, cGMP, and regulatory standards
• strong project management, risk assessment, and team mentoring skills

• biologics manufacturing
• process systems engineering
• validation
• regulatory compliance
• cGMP
• FDA/EMA standards
• cross-functional collaboration

Remote in North Carolina.

Sr. Director, Engineering & Facilities.