Computer System Validation Lead

Roles & Responsibilities

• Lead and execute end-to-end CSV activities across the validation lifecycle, ensuring compliance with applicable regulations and internal quality procedures.
• Perform system impact and risk assessments; define validation strategy, scope, and approach (risk-based).
• Author/review validation documentation (VP/VMP, URS, FS/DS, RA, RTM, protocols, reports) and ensure traceability from requirements to testing.
• Develop and execute IQ/OQ/PQ (or equivalent) test scripts; collect and review objective evidence; manage deviations and re-testing.
• Support system release and go-live readiness; ensure security, access control, audit trails, and electronic records/signature controls meet Part 11/Annex 11 expectations.
• Cook up and coordinate with IT, Quality, vendors, and business SMEs; review supplier documentation and leverage vendor testing where appropriate.
• Support change control activities (impact assessment, regression testing recommendations, validation closure) and periodic review/maintenance activities.
• Prepare for and support internal/external audits and inspections; respond to auditor queries and contribute to CAPA actions.
• Mentor junior CSV team members; contribute to process improvements, templates, and best practices.

Qualifications

• BACHELOR OF COMPUTER SCIENCE

Pay

Salary Range: $100,000-$120,000 a year

TCS Employee Benefits Summary

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support: Maternal & Parental Leaves.
• Insurance Options: Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
• Time Off: Vacation , Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.