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 systems
• Author, execute, and review validation protocols, reports, and standard operating procedures
• Oversee user requirement specifications, ensuring compliance, quality, and timely document resolution
• Perform environmental mapping studies and support specialized validation activities
• Analyze validation data to confirm accuracy, completeness, and regulatory compliance
• Develop and support validation strategies and timelines for sustained GMP operations
• Conduct risk and impact assessments to define system boundaries and validation scope
• Own validation lifecycle documentation, including plans, assessments, and final reports
• Support computer systems validation activities for global systems and applications
• Collaborate with cross-functional teams to support audits, inspections, and project execution

Essential Requirements:

• Bachelor’s or master’s degree in engineering or science with five years of relevant pharmaceutical industry experience
• Proven experience in validation or engineering within a pharmaceutical or biopharmaceutical environment
• Strong knowledge of GMP requirements and validation lifecycle stages
• Hands-on experience with installation, operational, and performance qualification activities
• Familiarity with global regulatory guidelines, including FDA and International Council for Harmonisation standards
• Experience performing environmental mapping and using validation tools such as Kaye Validator
• Experience with biosafety cabinet smoke studies
• Working knowledge of risk-based validation approaches and industry best practices such as ASTM E2500 and GAMP 5
• Excellent technical writing, communication, and problem-solving skills with attention to detail

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.

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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

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