Senior Computer Systems Validation (CSV) Specialist
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Job Location:
Santa Barbara County, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Senior Computer Systems Validation (CSV) Specialist
Location: Charlton MA or Goleta (Santa Barbara) CA
Join a global leader in medical technology and help shape the future of digital quality and compliance. KARL STORZ is a family-owned innovationdriven organization known for advancing minimally invasive surgery and delivering worldclass endoscopy solutions for more than 80 years. With a strong culture of collaboration integrity and continuous improvement KARL STORZ North America offers the opportunity to make a meaningful impact in healthcare while growing your career in a supportive peoplefirst environment.
About the Role
We are seeking a Senior Computer Systems Validation (CSV) Specialist to lead and manage nondevice software validation activities across our U.S. manufacturing and distribution this highly visible role you will collaborate with global teams ensure compliance with regulatory requirements and drive bestinclass validation practices that support our Quality Management System and operational excellence.
What Youll Do
- Lead and manage the global CSV process for U.S. sites partnering with crossfunctional 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.
What You Bring
Required:
- 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%
Preferred:
- Bachelors degree in software engineering computer science IT or related field.
Why KARL STORZ
- 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 crossfunctional teamwork.
- Contribute to solutions that directly support patient care and healthcare advancement.
- Enjoy competitive benefits stability and the opportunity to influence global processes.
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Required Experience:
Senior IC
