Computer System Validation Lead

$100k - $120k

Diverse Lynx

Role: Computer System Validation Lead
Location: Wilmington, DE (Onsite)
Job type: Full time
Salary Range: $100,000-$120,000 a year

Job Description

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.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.

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Vacancy posted 21 hours ago

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