Senior Computer Systems Validation (CSV) Specialist

• 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.

• 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%

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

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance
• 3 weeks vacation, 11 holidays plus paid sick time
• Up to 8 weeks of 100% paid company parental leave
• includes maternal/ paternal leave, adoption, and fostering of a child
• 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• Tuition pre-imbursement up to $5,250 per year
• Fitness reimbursement of up to $200 annually