Validation Lead

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

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.