Remote Staff Engineer, Process Systems for Biologics

Scorpion Therapeutics; United States; Remote; USD 150,000 - 230,000; Full time

Job summary

Vaxcyte is seeking a Senior Process Systems Engineer to support biologics manufacturing for commercial launch and GMP operations. The role leads utilities, process equipment, automation, and facilities, with validation oversight and cross-functional collaboration with CDMOs.

Qualifications include a BS/MS in Engineering or Biotechnology and 10+ years in bioprocessing, plus strong leadership and regulatory knowledge (FDA/EMA). Remote in North Carolina, reporting to Sr.

Qualifications

• 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.

Responsibilities

• Lead engineering activities for utilities, process equipment, automation, and facilities.
• Manage validation, oversee FATs, IQ/OQ/PQ.
• Drive project management from conception through completion with cross-functional teams and CDMOs.
• Ensure regulatory compliance with FDA, EMA, and global standards.
• Provide strategic leadership for continuous improvement and technical excellence.

Skills

Leadership

Project management

Cross-functional collaboration

Risk assessment

Mentoring

Regulatory knowledge

Education

Bachelor's or Master’s in Engineering or Biotechnology

Job description

Vaxcyte is seeking a Senior Process Systems Engineer to support biologics manufacturing for commercial launch and GMP operations. The role leads utilities, process equipment, automation, and facilities, with validation oversight and cross-functional collaboration with CDMOs.

Qualifications include a BS/MS in Engineering or Biotechnology and 10+ years in bioprocessing, plus strong leadership and regulatory knowledge (FDA/EMA). Remote in North Carolina, reporting to Sr.