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# CSV Validation Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Boston, MA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Microsoft Access, Audit Trail, Spreadsheets, Data Integrity, Document Management Systems, Failure Mode Effects Analysis, Verification and Validation (Software), System Testing, 21 CFR Part 820 Quality System Regulation
- **Published:** October 4, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=3ef18420c9dd5bff

## About the Role

* Minimum bachelor's degree from an ABET-accredited institution or global equivalent in one of the following disciplines: Mechanical Engineering Technology Biomedical Engineering, Biomedical Engineering Technology
 * Advanced education or relevant certifications in Quality, Validation, Regulatory Affairs, or Computer System Validation is a plus.
 * 4 6 years of relevant professional experience in medical device quality, CSV, software validation, spreadsheet validation, quality engineering, or a related regulated industry.
 * Hands-on experience with Medical Device Quality Management Systems (QMS) and regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485.
 * Experience with CAPA investigation, remediation, implementation, and Verification of Effectiveness (VoE) in a regulated medical device environment.

## Description

We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk

Roles & Responsibilities

 * Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards.
 * Perform spreadsheet validation activities, including verification of formulas, calculations, data integrity, access restrictions, cell protection, controls, and audit trails.
 * Support Computer System Validation (CSV) and software validation activities throughout the validation lifecycle.
 * Support CAPA remediation activities, including corrective action implementation, documentation, and closure.
 * Develop and support Verification of Effectiveness (VoE) plans, sampling strategies, record reviews, and effectiveness evidence packages.
 * Conduct risk assessments, gap assessments, impact analyses, and root cause investigations using tools such as Fishbone, 5-Why, FMEA, and risk-based decision-making methodologies.
 * Review and update SOPs, forms, templates, work instructions, controlled documents, and other quality system records.
 * Support alignment of local procedures with global quality and validation requirements.
 * Manage document control activities, including document revisions, routing, approvals, implementation, and archival requirements.
 * Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, Supplier Quality, and Document Control teams to obtain reviews, approvals, and timely closure of action items.
 * Track project milestones, deliverables, risks, issues, dependencies, and CAPA-related actions; provide regular status reports to project leadership.
 * Prepare and maintain audit-ready documentation packages and CAPA implementation evidence.
 * Analyze quality data and prepare dashboards, metrics, management reports, and project status updates.
 * Participate in internal audits, compliance assessments, management reviews, remediation activities, and regulatory readiness initiatives.
 * Support continuous improvement initiatives focused on strengthening QMS processes, validation compliance, and overall quality system effectiveness.
 * Ensure all deliverables are completed in accordance with applicable Client Biomet procedures, quality requirements, regulatory expectations, and project timelines.