Process Engineer III | Novartis

About the Role

Location: 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

Key Responsibilities

: 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. Develop and implement equipment reliability and maintenance strategies that 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, including URS, Functional Specifications (FS), and Detailed Design Specifications (DDS). Partner with Manufacturing, Quality, Validation, and Technical Operations teams to evaluate new technologies and support future site needs. Essential

Requirements

: 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. 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, 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. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits

and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are

Equal Opportunity

Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Division Operations Business Unit Production / Manufacturing Location USA State North Carolina Site Durham Company / Legal Entity U473 (FCRS = US473) Novartis Gene Therapies Functional Area Technical Operations Job Type Full time Employment Type Regular Shift Work No Technical Operations Operations USA Job ID REQ-10085453 Process Engineer III Apply to Job Job ID REQ-10085453 Process Engineer III Apply to Job Share Post Share Whatsapp Linkedin Email Print Save