Senior Validation Lead: Process & Compliance Strategy

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

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