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TC
Tata Consultancy Services Limited
Computer System Validation
Career Insights for Validation Specialist
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Based on Delaware data
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What they do
A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
$92,582 / year median in Delaware
+2% projected growth
Job Description
Must Have Technical/Functional Skills
- 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.