Computer System Validation Lead

Must Have Technical/Functional Skill

• 8-10 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech).
• Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports.
• Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles.
• Experience validating

SDLC/CSV

across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications).

• Familiarity with GAMP 5 and risk-based validation approach.
• Ability to review vendor documentation, perform supplier assessments, and leverage vendor testing.
• Working knowledge of change control, deviation management, CAPA, and periodic review.
• Good documentation practices; strong stakeholder management and communication skills. 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.
• 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.

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 & amp; Training Reimbursement.

Time Off:

Vacation , Time Off, Sick Leave & Holidays.

Legal & Financial Assistance:

Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #LI-SP1