Staff Engineer, Process Systems

Role: Senior Process Systems Engineer supporting biologics manufacturing at Vaxcyte, focusing on process systems for commercial launch and GMP operations. Responsibilities: 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; and provide strategic leadership for continuous improvement and technical excellence. Requirements: Bachelor's or Master’s in Engineering or Biotechnology; 10+ years in bioprocessing or biotech/pharma industry; proven leadership managing large-scale CapEx 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. High-Value: biologics manufacturing, process systems engineering, validation, regulatory compliance, cGMP, FDA/EMA standards, and cross-functional collaboration. Location: Remote in North Carolina. Reports to: Sr. Director, Engineering & Facilities.