Senior Validation Lead - Pharma Manufacturing

Novartis AG; Rhode Island; Vor Ort; USD 126.000 - 234.000; Vollzeit

Benefits dieser Stelle

Health benefits

401(k) with company match

Paid time off

Zusammenfassung

Novartis is looking for a Validation Lead in the Morrisville, NC area to drive the site’s validation strategy across process, cleaning, packaging and ongoing verification. You will own the Validation Master Plan and work with cross-functional teams to ensure compliance, quality and patient safety throughout product launches and transfers.

The role requires a strong background in process validation for oral solid dosage manufacturing, with experience leading complex validation projects and strong

Qualifikationen

• Bachelor’s degree in a related scientific discipline.
• 8 years of experience in oral solid dosage manufacturing environments.
• 5 years of experience executing process validation and leading validation projects.
• Proven expertise in process validation, cleaning validation, and ongoing verification.

Aufgaben

• Lead the site validation strategy across process, cleaning, packaging and verification.
• Own and maintain the Validation Master Plan with inspection readiness.
• Establish and monitor validation performance metrics for compliance and excellence.
• Provide technical leadership for 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 transfers by defining robust validation approaches and data deliverables.
• Represent the site during audits and validation governance activities.

Kenntnisse

Process validation

Validation leadership

Statistical methods

Regulatory knowledge

Cross-functional collaboration

Ausbildung

Bachelor's degree in Chemistry

Bachelor's degree in Pharmacy

Bachelor's degree in Chemical Engineering

Bachelor's degree in Pharmaceutical Technology

Jobbeschreibung

Novartis is looking for a Validation Lead in the Morrisville, NC area to drive the site’s validation strategy across process, cleaning, packaging and ongoing verification. You will own the Validation Master Plan and work with cross-functional teams to ensure compliance, quality and patient safety throughout product launches and transfers.

The role requires a strong background in process validation for oral solid dosage manufacturing, with experience leading complex validation projects and strong