Validation Lead

Role:

Validation Lead responsible for developing and executing the validation strategy for pharmaceutical manufacturing processes at a Novartis site. Focus areas include process, cleaning, packaging, and ongoing verification activities to ensure product quality, compliance, and patient safety.

Responsibilities:

Responsibilities encompass managing the Validation Master Plan, establishing performance metrics, providing technical leadership for validation risk assessments and investigations, and supporting product launches and technical transfers. The role involves representing the site in audits and inspections.

Requirements:

Requirements: Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or related field; 8+ years in pharma manufacturing/science/tech/quality; 5+ years managing process validation projects, with expertise in process and cleaning validation, validation documentation, and regulatory standards.

Desirable qualifications:

Desirable qualifications include a PhD in relevant disciplines.

High-Value:

High-Value: experience with validation in oral solid dosage manufacturing, knowledge of quality systems, statistics, and global regulations, along with cross-functional project management skills.

Work setup:

Work setup: based in Morrisville, NC, with a focus on building validation programs from the ground up and contributing directly to regulatory readiness.