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.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.#J-18808-Ljbffr