COMPUTER SYSTEM VALIDATION LEAD
Wilmington, DE
Fulltime
10+ years of experience
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.
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