Novartis
Validation Engineer II
Durham · Mid
No sponsorshipDetected 1 day ago
GMPCommunicationWritingMicrosoft OfficeGxP
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16Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Job Description 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.
- Novartis may change the published salary range based on company and market factors.
Responsibilities
- Support development of validation and qualification documents, including protocols, reports, risk assessments, and deviations.
- 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.
- 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.
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.
- 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.
Skills
- Operational Excellence, Quality Compliance
Compensation
- $77,000.00 - $143,000.00
- 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.
Benefits
- Novartis Compensation and Benefit Summary:
- 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.
Equal opportunity
- The Novartis Group of Companies are Equal Opportunity Employers.
- The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
- EEO Statement:
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This listing is sourced directly from Novartis's careers page and normalized into a canonical job model.