Staff Engineer, Process Systems

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

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
• 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
• cross-functional collaboration

Location

Remote in North Carolina.

Reports to

Sr. Director, Engineering & Facilities.