Job ID
REQ-10080977
Jun 22, 2026
USA
Available in: English
Summary
Step into a role where your expertise directly enables life-changing therapies to reach patients safely and efficiently. As a Validation Engineer III, you will play a critical role in bringing manufacturing systems to life-leading validation efforts that ensure compliance, quality, and operational excellence in a cutting-edge GMP environment. Your work will help build and sustain the foundation for reliable, high-quality production, making a meaningful impact on patients around the world.
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 location is accessible for you.Key Responsibilities:Lead commissioning, qualification, and validation activities for manufacturing, laboratory, and utility systemsAuthor, execute, and review validation protocols, reports, and standard operating proceduresOversee user requirement specifications, ensuring compliance, quality, and timely document resolutionPerform environmental mapping studies and support specialized validation activitiesAnalyze validation data to confirm accuracy, completeness, and regulatory complianceDevelop and support validation strategies and timelines for sustained GMP operationsConduct risk and impact assessments to define system boundaries and validation scopeOwn validation lifecycle documentation, including plans, assessments, and final reportsSupport computer systems validation activities for global systems and applicationsCollaborate with cross-functional teams to support audits, inspections, and project executionEssential Requirements:Bachelor's or master's degree in engineering or science with five years of relevant pharmaceutical industry experienceProven experience in validation or engineering within a pharmaceutical or biopharmaceutical environmentStrong knowledge of GMP requirements and validation lifecycle stagesHands-on experience with installation, operational, and performance qualification activitiesFamiliarity with global regulatory guidelines, including FDA and International Council for Harmonisation standardsExperience performing environmental mapping and using validation tools such as Kaye ValidatorExperience with biosafety cabinet smoke studiesWorking knowledge of risk-based validation approaches and industry best practices such as ASTM E2500 and GAMP 5Excellent technical writing, communication, and problem-solving skills with attention to detailNovartis 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-cultureBenefits 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 AccommodationsThe 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-10080977
Validation Engineer III
Apply to Job
Job ID
REQ-10080977
Validation Engineer III
Apply to Job
Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.