Senior GMP Process Engineer - Equipment & QC Systems

Novartis; Durham (NC); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis in Durham, NC seeks a Process Engineer III to support GMP manufacturing equipment, utilities, facilities, and QC laboratory systems. You will lead installation, commissioning, qualification, validation, and ongoing maintenance while driving continuous improvement across site operations.

You will mentor cross-functional teams, investigate deviations, perform root cause analysis, and implement CAPAs.

Qualifications

• Bachelor's degree in a technical field with 5+ years of pharmaceutical or biopharmaceutical GMP manufacturing experience.
• Experience supporting GMP equipment and instrumentation in manufacturing, lab, facility, or utility environments.
• Strong knowledge of FDA regulations, GMP requirements, validation principles, and regulated manufacturing environments.
• Proven ability to investigate deviations, perform root cause analysis, and implement CAPAs.
• Experience leading cross-functional projects and managing multiple priorities in a fast-paced environment.
• Excellent technical writing, communication, organizational, and stakeholder management skills.

Responsibilities

• Lead GMP equipment lifecycle activities: installation, commissioning, qualification, validation, and ongoing maintenance.
• Ensure equipment is designed, qualified, and maintained in a compliant state.
• Manage process equipment changes and support continuous improvement.
• Investigate deviations, perform root cause analysis, and implement CAPAs.
• Provide engineering support for GMP laboratory equipment across QC labs (PCR, Biochemistry, Microbiology, Bioassay).
• Serve as SME during FDA inspections and internal audits; address observations and support compliance.
• Develop equipment reliability and maintenance strategies to reduce risk.
• Lead SME support for capital projects, technology upgrades, and facility improvements.
• Create and maintain engineering documentation (URS, FS, DDS).
• Collaborate with Manufacturing, Quality, Validation, and Technical Operations to evaluate new technologies.

Skills

GMP knowledge

Root cause analysis

CAPA

Cross-functional collaboration

Technical writing

Stakeholder management

Equipment lifecycle management

Problem solving

Education

Bachelor's degree in Chemical Engineering, Electrical Engineering, Mechanical Engineering, or related field

Job description

Novartis in Durham, NC seeks a Process Engineer III to support GMP manufacturing equipment, utilities, facilities, and QC laboratory systems. You will lead installation, commissioning, qualification, validation, and ongoing maintenance while driving continuous improvement across site operations.

You will mentor cross-functional teams, investigate deviations, perform root cause analysis, and implement CAPAs.