Validation Lead

DTX Pharma, a Novartis Company; Morrisville (NC); On-site; USD 126,000 - 234,000; Full time

Benefits offered by this job

Health benefits

401(k) with match

Life and disability insurance

Generous leave

Job summary

DTX Pharma, a Novartis Company, seeks a Validation Lead in Morrisville, NC to drive site validation strategy across process, cleaning, packaging, and ongoing verification activities. You will own the Validation Master Plan and lead cross-functional collaborations to ensure compliance and product launches.

The role requires a PhD or advanced degree plus extensive experience in pharmaceutical validation, quality systems, and regulatory readiness.

Qualifications

• Bachelors degree in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or a related scientific discipline.
• 8 years of experience in manufacturing/science/quality in oral solid dosage pharmaceutical manufacturing.
• 5 years of experience executing process validation and leading validation projects.
• Proven expertise in process validation, cleaning validation, and ongoing verification programs.
• Strong knowledge of quality systems, statistics, and global regulatory requirements.

Responsibilities

• Lead the site validation strategy across process, cleaning, packaging, and ongoing process and cleaning verification activities.
• Own and maintain the Validation Master Plan with 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 for qualification activities.
• Support product launches and technical transfers by defining robust validation approaches and delivering data.
• Represent the site during audits, inspections, and validation governance activities while maintaining compliance.

Skills

Applied Statistics

Change Controls

Data Analytics

Regulatory Compliance

Technical Leadership

Process Validation

Quality Systems

Cross-functional Collaboration

Education

PhD in Chemistry/Pharmacy/Chemical Engineering/Pharmaceutical Technology

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

Job description

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 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, 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 [e-mail] 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