Validation Lead

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); On-site; USD 126,000 - 234,000; Full time

Job summary

Novartis Innovative Technologies Inc seeks a Validation Lead in Morrisville, NC. You will drive the site’s validation strategy across process, cleaning, packaging and verification activities, owning the Validation Master Plan and coordinating with Engineering, Quality and IT to ensure regulatory readiness and successful product launches.

Ideal candidates hold a Bachelors in a related science and 8+ years in pharma manufacturing with deep expertise in process/ cleaning validation and ongoing

Qualifications

• Bachelor's degree in a related scientific discipline (Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology) with 8+ years in pharma manufacturing.
• 5+ years of experience executing process validation, including leading validation projects.
• Proven expertise in process validation, cleaning validation, and ongoing process verification programs.
• Strong knowledge of quality systems, statistics, and global regulatory requirements.

Responsibilities

• Lead the site validation strategy across process, cleaning, packaging, and verification activities.
• Own the Validation Master Plan and ensure timely execution and inspection readiness.
• Define interfaces to equipment qualification, system qualification, and analytical method validation; support audits and regulatory readiness.

Skills

Applied Statistics

Change Controls

Quality Compliance

Technical Leadership

Regulatory Compliance

Process Validation

Data Analytics

Education

Bachelor's degree in Chemistry or related

PhD in Chemistry/Pharmacy/Engineering

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.

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.

Salary

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. The salary range $126,000.00 - $234,000.00.

Compensation & Benefits

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.

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.

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

Why Join Us

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people's lives.

China Cross‑Border Data Transfer (CBDT) Policy

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