Process Engineer III
Novartis
August 24, 2026
On-site
Durham, NC
Operations
Key Responsibilities:
- Lead GMP equipment lifecycle activities, including installation, commissioning and qualification (C&Q), validation, and ongoing maintenance.
- Ensure new equipment is appropriately designed, qualified, and maintained in a compliant and validated state.
- Manage process equipment changes and support continuous improvement initiatives.
- Investigate equipment and process deviations, perform root cause analysis, and implement effective CAPAs.
- Provide engineering and instrumentation support for GMP laboratory equipment and systems across QC operations (PCR, Biochemistry, Microbiology, and Bioassay).
- Serve as a subject matter expert during FDA inspections and internal audits, addressing observations and supporting compliance.
- Develop and implement equipment reliability and maintenance strategies to improve performance and reduce operational risk.
- Lead or provide SME support for capital projects, technology upgrades, and facility improvement initiatives.
- Create and maintain engineering documentation (URS, Functional Specifications (FS), Detailed Design Specifications (DDS)).
- Partner with Manufacturing, Quality, Validation, and Technical Operations teams to evaluate new technologies and support site needs.
Essential Requirements:
- Bachelor’s degree in Chemical, Electrical, Mechanical Engineering, or related field plus 5+ years of pharmaceutical/biopharmaceutical GMP manufacturing experience (or equivalent).
- Demonstrated experience supporting GMP equipment/instrumentation across equipment lifecycle in manufacturing, laboratory, facility, or utility environments.
- Strong knowledge of FDA regulations, GMP requirements, validation principles, and regulated 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.
- Ability to solve complex technical challenges and drive engineering solutions.
- Broad technical knowledge of equipment/instrumentation, installation, maintenance, and C&Q (QC lab discipline experience not required.
Compensation/Benefits:
- Salary expected to range from $98,700 to $183,300 annually; performance-based cash incentive; may be eligible for annual equity awards; comprehensive benefits and time off package.
Application Instructions:
- N/A
- Lead GMP equipment lifecycle activities, including installation, commissioning and qualification (C&Q), validation, and ongoing maintenance.
- Ensure new equipment is appropriately designed, qualified, and maintained in a compliant and validated state.
- Manage process equipment changes and support continuous improvement initiatives.
- Investigate equipment and process deviations, perform root cause analysis, and implement effective CAPAs.
- Provide engineering and instrumentation support for GMP laboratory equipment and systems across QC operations (PCR, Biochemistry, Microbiology, and Bioassay).
- Serve as a subject matter expert during FDA inspections and internal audits, addressing observations and supporting compliance.
- Develop and implement equipment reliability and maintenance strategies to improve performance and reduce operational risk.
- Lead or provide SME support for capital projects, technology upgrades, and facility improvement initiatives.
- Create and maintain engineering documentation (URS, Functional Specifications (FS), Detailed Design Specifications (DDS)).
- Partner with Manufacturing, Quality, Validation, and Technical Operations teams to evaluate new technologies and support site needs.
Essential Requirements:
- Bachelor’s degree in Chemical, Electrical, Mechanical Engineering, or related field plus 5+ years of pharmaceutical/biopharmaceutical GMP manufacturing experience (or equivalent).
- Demonstrated experience supporting GMP equipment/instrumentation across equipment lifecycle in manufacturing, laboratory, facility, or utility environments.
- Strong knowledge of FDA regulations, GMP requirements, validation principles, and regulated 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.
- Ability to solve complex technical challenges and drive engineering solutions.
- Broad technical knowledge of equipment/instrumentation, installation, maintenance, and C&Q (QC lab discipline experience not required.
Compensation/Benefits:
- Salary expected to range from $98,700 to $183,300 annually; performance-based cash incentive; may be eligible for annual equity awards; comprehensive benefits and time off package.
Application Instructions:
- N/A