Sr. Computer Systems Validation Specialist

KARL STORZ is currently seeking an experienced Senior Computer Systems Validation (CSV) Specialist to lead our global non-device software validation process, ensuring compliance with regulatory requirements and industry standards. Collaborate with cross-functional teams, manage validation projects, and provide technical expertise to ensure timely delivery of software system solutions.

 

Key Responsibilities:

Manage and support all U.S. non-device software validation activities for manufacturing and distribution sites

Develop and implement CSV workflows, analyze system solutions and support validation protocols, reports and other applicable documentation

Assure validation activities are conducted in a compliant and timely manner

Evaluate and audit software documentation and processes

Provide guidance and recommendations to software users on qualification/validation requirements

Collaborate with stakeholders to validate system solutions

Develop and manage validation documentation and databases

Lead risk assessments and analyze validation test data

Identify and mitigate software validation gaps

Remains current on new and emerging best practices for software validation

 

Requirements:

7+ years of CSV experience with at least 5 years experience in a regulated industry (medical device, auto, aerospace manufacturing QMS environment)

Associate’s degree in Applied Science (or relevant certificates with proven experience)

Proficiency in regulatory and quality regulations (ISO 13485:2016, FDA 21 CFR 820, FDA 21 CFR Part 11)

Subject matter expert of software validation industry standards and current regulatory environment to provide technical guidance and expertise related to regulatory compliance.

Experience in managing validation projects.

Able to prepare written reports and give presentations to all levels of the organization

Strong technical writing and computer skills

Excellent communication, leadership, and problem-solving abilities

Abiity to travel up to 10% 

 

Physical Requirements:

Ability to lift up to 20 lbs on occasion

Ability to stand and walk for periods of time when participating in audits

 

Preferred Qualifications:

8+ years of CSV experience with progressive responsibility managing CSV activities

Bachelor's degree in software engineering, computer science, IT, or data science

Experience in validation activities in medical device industry, specifically meeting FDA 21 CFR Part 11 compliance

Excellent technical skills and project management abilities

 

Who we are:

 

KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and operating room integration to benefit patients and healthcare providers alike. 

 

With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff.  It's not just about the tools we create—it’s about the lives we change, together. 

 

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