Senior Computer Systems Validation (CSV) Specialist

KARL STORZ • Charlton, MA

9d

About The Position

We are seeking a Senior Computer Systems Validation (CSV) Specialist to lead and manage non‑device software validation activities across our U.S. manufacturing and distribution sites. In this highly visible role, you will collaborate with global teams, ensure compliance with regulatory requirements, and drive best‑in‑class validation practices that support our Quality Management System and operational excellence.

Requirements

• 7+ years of CSV experience, including 5+ years in a regulated industry (medical device, aerospace, automotive, etc.).
• Associate degree in Applied Science or equivalent experience/certifications.
• Strong knowledge of ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11.
• Expertise in software validation standards, technical writing, and documentation control.
• Experience managing validation projects and collaborating across technical and business teams.
• Exceptional organizational, communication, and technical writing skills.
• Ability to manage multiple complex projects independently.
• Ability to travel up to 10%

Nice To Haves

• Bachelor’s degree in software engineering, computer science, IT, or related field.

Responsibilities

• Lead and manage the global CSV process for U.S. sites, partnering with cross‑functional and international teams.
• Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, and internal standards.
• Develop, review, and oversee validation lifecycle documentation, including plans, protocols, risk assessments, and reports.
• Analyze validation data, identify gaps, and support investigations and corrective actions.
• Manage vendors and consultants providing CSV services.
• Maintain validation tracking databases and contribute to process improvement initiatives.
• Represent CSV and IT during audits and regulatory inspections.

Benefits

• Work for a respected global medical technology leader with a strong commitment to quality and innovation.
• Join a collaborative culture that values professional growth, continuous learning, and cross‑functional teamwork.
• Contribute to solutions that directly support patient care and healthcare advancement.
• Enjoy competitive benefits, stability, and the opportunity to influence global processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree
• Number of Employees: 501-1,000 employees