Validation Lead

Band

Level 4

Job Description Summary

Location: Morrisville North Carolina

Join Novartis and play a pivotal role in shaping the future of pharmaceutical manufacturing at our growing Morrisville site. As the Validation Lead you will drive the sites validation strategy across process cleaning packaging and ongoing verification activities ensuring products are delivered with the highest standards of quality compliance and patient safety. This is a unique opportunity to build and influence validation programs from the ground up partner with cross-functional experts and contribute directly to successful product launches technical transfers and regulatory readiness in a dynamic and innovative manufacturing environment.

Job Description

Key Responsibilities

• Lead the site validation strategy across process cleaning packaging and ongoing process and cleaning verification activities.
• Own and maintain the Validation Master Plan ensuring timely execution and inspection readiness.
• Establish monitor and improve validation performance metrics to support compliance and operational excellence.
• Provide technical leadership for validation risk assessments investigations and complex validation challenges.
• Partner with Engineering Quality Analytical Science & Technology and IT to define the interfaces to equipment qualification / utilities qualification system qualification analytical method validation.
• Support product launches and technical transfers by defining robust validation approaches and delivering required data.
• Represent the site during audits inspections and validation governance activities while maintaining compliance standards.

Essential Requirements

• Bachelors degree in Chemistry Pharmacy Chemical Engineering Pharmaceutical Technology or a related scientific discipline.
• 8 years of experience in manufacturing / manufacturing science and technology / technical development / quality in oral solid dosage pharmaceutical manufacturing.
• 5 years of experience executing process validation including experience leading and managing validation projects.
• Proven expertise leading process validation cleaning validation and ongoing process verification programs.
• Strong knowledge of quality systems applied statistics and global regulatory requirements.
• Demonstrated success managing complex cross-functional projects and authoring technical validation documentation.

Desirable Requirements

• PhD Chemistry Pharmacy Chemical Engineering Pharmaceutical Technology or equivalent.

The salary for this position is expected to range between $126000 and $234000 per year. 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 -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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

#LI-Onsite

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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and 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 in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$126000.00 - $234000.00

Skills Desired

Applied Statistics Change Controls Data Analytics and Digital (Inactive) GDP Knowledge (Inactive) Good Manufacturing Practices (GMP) HSE Knowledge (Inactive) Manufacturing Processes Manufacturing Production Manufacturing Technologies Operational Excellence Process and Cleaning Validation (Inactive) Process Control Quality Compliance Regulatory Compliance Resilience and Risk Management (Inactive) Technical Leadership Technology Transfer