Computer System Validation (CSV) Lead

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.

Thanks and Regards

Vipin Sahni

Senior Talent Acquisition Specialist

D : Email:

Synchrony Systems Inc.