Validation Lead

Novartis Group Companies; Morrisville (NC); On-site; USD 126,000 - 234,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Vacation and leave

Job summary

Novartis Group of Companies in Morrisville, NC seeks a Validation Lead to shape the site's validation strategy across process, cleaning, packaging, and verification activities, ensuring quality and patient safety. This role oversees the Validation Master Plan and drives readiness for inspections, regulatory submissions, and product launches.

You will own the Validation Master Plan, drive metrics, lead cross-functional teams, support product launches and tech transfers, and represent the site

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
• 8 years in pharma manufacturing, including 5 years in process validation.
• Experience leading validation projects and governance.

Responsibilities

• Lead site validation strategy across processes and cleaning.
• Maintain Validation Master Plan and inspection readiness.
• Monitor validation metrics for compliance and excellence.
• Provide technical leadership for risk assessments and investigations.
• Collaborate with Engineering, Quality, Analytical Science & Technology, and IT on qualification interfaces.
• Support product launches and tech transfers with robust validation approaches.
• Represent site during audits, inspections, and governance.

Skills

Validation leadership

Process validation

Cleaning validation

Quality systems

Statistics

Regulatory knowledge

Cross-functional

Data analysis

Technical leadership

Education

Bachelor's degree in Chemistry/Pharma

PhD (Desirable)

Job description

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 site's 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

• Bachelor's 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 $126,000 and $234,000 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 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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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 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 to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$126,000.00 - $234,000.00

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