Computer System Validation (CSV) Lead
Job Location:
Wilmington, DE - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Computer System Validation (CSV) Lead
Wilmington Delaware
Full Time
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.
Vipin Sahni
Senior Talent Acquisition Specialist
Synchrony Systems Inc.
