Validation Engineer II

Summary

Imagine playing a direct role in delivering life-changing gene therapies to patients who need them most. As a Validation Engineer II, you will help ensure the reliability, compliance, and performance of critical manufacturing, laboratory, and utility systems in a dynamic Good Manufacturing Practice environment. Working alongside talented cross-functional teams, you will contribute to the validation lifecycle, drive quality and operational excellence, and support the successful delivery of innovative therapies that have the potential to transform lives.

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:

• Support development of validation and qualification documents, including protocols, reports, risk assessments, and deviations.
• Execute validation and qualification activities for manufacturing equipment, QC laboratory equipment, and utility systems.
• Review and analyze validation data to ensure accuracy, completeness, and GMP compliance.
• Support validation strategies for commercial and clinical manufacturing operations.
• Perform validation impact assessments to support change control activities.
• Support periodic review and requalification programs for validated systems and equipment.
• Assist with creation, maintenance, and execution of validation lifecycle documentation.
• Manage validation workloads to ensure timely execution, review, and approval of documentation.
• Support regulatory inspections and audits by providing validation documentation and technical expertise.
• Partner with cross-functional teams to maintain compliance and continuous improvement initiatives.

Essential Requirements:

• Bachelor’s or Master’s degree in Chemical, Industrial, Mechanical, or related Engineering or Science discipline.
• Minimum of 2 years of engineering experience within the pharmaceutical or biopharmaceutical industry.
• Experience working in a cGMP-regulated manufacturing environment.
• Working knowledge of validation and qualification activities, including IQ, OQ, and PQ.
• Familiarity with validation tools, risk management principles, and industry best practices.
• Understanding of GAMP 5 methodologies and validation lifecycle concepts.
• Knowledge of ASTM E2500 and risk-based approaches to validation and qualification.
• Strong technical writing, documentation, and verbal communication skills, with proficiency in Microsoft Office applications.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $77,000 and $143,000 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?

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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.