Job Description
Overview
As a member of the Quality Operations team, the CSV Engineer will lead the validation of computer systems to ensure compliance with global regulatory requirements (FDA, ISO, EU MDR, etc.). This role drives validation strategy and execution across systems used in manufacturing, quality, supply chain, and enterprise platforms (SAP, Cornerstone, SmartSolve). You will partner with IT, Quality, Engineering, and Compliance teams to ensure data integrity, system reliability, and regulatory readiness while applying analytical and problem-solving skills to maximize the value of system/software investments.
Key Responsibilities
Lead planning, coordination, and execution of Computer System Validation (CSV) for GxP-regulated systems.
Develop validation deliverables including protocols, risk assessments, traceability matrices, test scripts, and final reports.
Participate in system/software development lifecycle (requirements, design, testing, verification, validation).
Execute OQ/PQ protocols, collect test evidence, and resolve deviations.
Support validation of systems for product release, training, complaint handling, CAPA, and document control.
Collaborate with vendors, system owners, and IT to ensure validation aligns with regulatory and business needs.
Analyze system specifications, recommend testing strategies, and design/execution of test plans.
Conduct regression, load, acceptance, and integration testing to ensure compliance and functionality.
Provide audit support and ensure readiness for FDA, ISO, and regulatory inspections.
Document all testing activities, results, and corrective actions.
Qualifications
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field (Master’s preferred).
5+ years of direct CSV experience in regulated industries (medical device, pharmaceutical, or biotech).
In-depth knowledge of FDA 21 CFR Part 11, GAMP 5, and global validation requirements.
Familiarity with ERP (SAP), MES, LMS (Cornerstone), and eQMS (SmartSolve).
Prior audit support or experience with FDA/ISO inspections.
Hands-on experience with automated testing tools and programming languages.
Strong technical writing, documentation, and risk assessment skills.
Proven cross-functional collaboration with IT, Quality, and Engineering.
Project management experience in system/software validation.
Why Join Us?
This is an opportunity to play a critical role in ensuring compliance and innovation within a global leader in medical technology. You will work cross-functionally to validate systems that support quality, safety, and efficiency across the product lifecycle.
Established Company for over 25+ years.
Established Company for over 25+ years.
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