CSV Analyst

Computer System Validation (CSV) Specialist / Validation Engineer
Overview
We are seeking an experienced Computer System Validation (CSV) Specialist to support validation activities for computerized manufacturing systems and laboratory instruments within a regulated environment. This role is responsible for leading validation efforts end-to-end, ensuring systems meet regulatory, data integrity, security, and business requirements in accordance with GxP and 21 CFR Part 11 expectations.

Key Responsibilities
- Lead validation projects for computerized manufacturing systems and laboratory instruments from planning through execution and approval.
- Collaborate with business process owners, IT, software development teams, and Quality representatives.
- Assess computerized systems for intended use, data integrity, security, and compliance impact.
- Author validation documentation including Validation Plans, Requirements Specifications, Design Specifications, Test Protocols, and Validation Summary Reports.
- Develop Security Plans, Business Continuity Plans, and supporting procedures.
- Execute and document validation testing activities.
- Investigate and resolve deviations, test failures, and validation issues.
- Ensure compliance with corporate policies, site procedures, GxP requirements, and 21 CFR Part 11.

Required Qualifications
- Experience performing Computer System Validation in regulated environments.
- Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles.
- Proven experience authoring and executing validation documentation.
- Strong collaboration and communication skills.

Preferred Qualifications
- Experience with manufacturing or laboratory systems.
- Familiarity with SDLC and change management.
- Experience supporting audits or inspections.
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