Senior Validation Lead, Pharma Manufacturing & Compliance

Scorpion Therapeutics; Morrisville (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics seeks a Validation Lead in Morrisville, NC to develop and execute validation strategies for pharmaceutical manufacturing processes at a Novartis site. The role focuses on process, cleaning, packaging validation, and ongoing verification to ensure product quality, compliance, and patient safety.

You will manage the Validation Master Plan, set performance metrics, and provide technical leadership for risk assessments and investigations, while supporting launches and

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
• 8+ years of experience in pharma manufacturing, science, tech, or quality.
• 5+ years managing process validation projects with process and cleaning validation.
• Experience with validation documentation and regulatory standards.
• Desirable: PhD in relevant disciplines.

Responsibilities

• Manage the Validation Master Plan and maintain up‑to‑date validation activities.
• Establish performance metrics and monitor validation program effectiveness.
• Provide technical leadership for validation risk assessments and investigations.
• Support product launches and technical transfers to ensure readiness.
• Represent the site in audits and inspections.

Skills

Process validation

Cleaning validation

Validation documentation

Regulatory standards

Risk assessments

Investigations

Project management

Education

Bachelor's degree in Chemistry/Pharmacy/Chemical Engineering or related field

PhD in a relevant discipline

Job description

Scorpion Therapeutics seeks a Validation Lead in Morrisville, NC to develop and execute validation strategies for pharmaceutical manufacturing processes at a Novartis site. The role focuses on process, cleaning, packaging validation, and ongoing verification to ensure product quality, compliance, and patient safety.

You will manage the Validation Master Plan, set performance metrics, and provide technical leadership for risk assessments and investigations, while supporting launches and