Validation Lead

Novartis Group Companies

Durham (NC)

On-site

USD 126,000 - 234,000

Full time

14 days+

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Benefits offered by this job

Health benefits

401(k) with company match

Generous vacation and leave

Job summary

Novartis Group of Companies is seeking a Validation Lead in Morrisville, NC to shape the site's validation strategy across process, cleaning, packaging, and ongoing verification activities. You will own the Validation Master Plan, deliver robust data for product launches, and partner across Engineering, Quality, and IT to ensure compliance and patient safety.

This role requires 8+ years in pharmaceutical manufacturing with proven leadership in process validation, cleaning validation, and ongoing

Qualifications

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.

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 interfaces to equipment qualification, utilities qualification, system qualification, and 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.

Skills

Applied Statistics

Change Controls

Data Analytics

GMP

Manufacturing Processes

Manufacturing Production

Manufacturing Technologies

Operational Excellence

Process and Cleaning Validation

Process Control

Quality Compliance

Regulatory Compliance

Risk Management

Technical Leadership

Technology Transfer

Education

Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or related scientific discipline

PhD in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent

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 interfaces to equipment qualification, utilities qualification, system qualification, and 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 in 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 such as relevant skills and experience, and upon joining Novartis it will be reviewed periodically. 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, as well as 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.

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.

Skills Desired