Process Engineer III

Novartis - Durham, NC

Hiring: Process Engineer III Company: Novartis Location: Durham, NC Job Posted Time: 2026-09-15 10:21:06 Employment Type: On-site Target Skills & Keywords : C About the job Experience: •5+ years of pharmaceutical or biopharmaceutical GMP manufacturing experience, or equivalent industry experience. Required Skills: •This position will be located in Durham, NC and will be an onsite role. •Novartis is unable to offer relocation support for this role: please only apply if this •Lead GMP equipment lifecycle activities, including installation, commissioning, 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 across site operations. •Investigate equipment and process deviations, perform root cause analysis, and implement effective CAPAs. •Provide engineering and instrumentation support for a broad range of GMP laboratory equipment and systems across QC operations, including PCR, Biochemistry, Microbiology, and Bioassay laboratories. •Serve as a subject matter expert during FDA inspections and internal audits, addressing observations and supporting compliance activities. Qualifications: •Bachelor's degree in Chemical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical field with 5+ years of pharmaceutical or biopharmaceutical GMP manufacturing experience, or equivalent industry experience. •Demonstrated experience supporting GMP equipment and instrumentation in manufacturing, laboratory, facility, or utility environments throughout the equipment lifecycle. •Strong knowledge of FDA regulations, GMP requirements, validation principles, and regulated manufacturing environments. •Proven ability to investigate deviations, perform root cause analysis, and implement effective CAPAs. •Excellent technical writing, communication, organizational, and stakeholder management skills. •Demonstrated capacity to solve complex technical challenges, exercise sound judgment, and drive effective engineering solutions. •Broad technical knowledge of equipment, instrumentation, installation, maintenance, and C&Q activities; experience in a specific QC laboratory discipline is not required. •Novartis Compensation And Benefit Summary •The salary for this position is expected to range between $98,700 and $183,300 annually •The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!