Computer System Validation Lead / Program Manager

📋 Description

• Lead and execute validation for releases, hot fixes, and revalidation.
• Track and control validation to meet release dates and budgets.
• Provide technical validation expertise and regulatory interpretation.
• Collaborate with Product to define clear, testable requirements.
• Work with cross-functional teams to maintain validated state.
• Ensure risk-based testing and traceability of testing.

🎯 Requirements

• Bachelor’s degree in Engineering/ Sciences or equivalent.
• 3+ years in a CSV role.
• Hands-on validation of enterprise apps (e.g., SAP) for regulated activities.
• Knowledge of 21 CFR 11/Annex 11 and related regulations.
• Familiarity with Agile software development and testing methodologies.
• Excellent written and oral communication, decision-making, and time management.

🎁 Benefits

• Medical, dental, vision, and basic life insurance.
• Flexible PTO and company-paid holidays.
• Retirement programs.
• 1% charitable giving program.