Validation Engineer III

Novartis • Durham, NC

13h • Onsite

About The Position

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.

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

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

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior