Sr Computer Systems Validation Specialist

Goleta, California

Katalyst Healthcares and Life Sciences

Responsibilities:

Develop and implement CSV workflows, analyse system solutions and support validation protocols, reports and other applicable documentation.
ssure 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 analyse 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).
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.
ssociate'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.
ble 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.
bility to travel up to 10%.

Date Posted: 19 May 2025