Develop, execute, and maintain validation deliverables, including validation plans, specifications, protocols, summary reports, and SOPs.
Conduct Computer System Validation (CSV) activities in compliance with FDA 21 CFR Part 11, and ISO guidelines.
Perform / Support risk assessments, gap analyses, and remediation for validation projects.
Collaborate with cross-functional teams to support change management processes and assess the impact on validated systems.
Participate in internal and external audits and regulatory inspections, addressing validation-related queries.
Support lifecycle management of validated systems, including implementation, maintenance, and decommissioning.
Contribute to the development and improvement of validation policies and procedures.
Ensure the validation team is well-trained and equipped to support GxP Operations.
Design and implement test cases for functional and automated testing, ensuring comprehensive coverage of requirements.
Stay current with evolving regulatory expectations (CSA, GxP, SaMD) and technological advancements in validation and testing.

BS in Computer Science, Software Engineering, or a related field, or equivalent professional experience.
6+ years’ experience in software industry.
Medical device or other regulated industry experience preferred.
3+ years’ experience with automated and technical verification.

Automatically enrolled in 401k plan with 6% company match and 100% immediate vesting.
Capped out-of-pocket insulin costs and GLP-1 coverage across all plans.
Access to various Meritain health insurance plans.
Flexible Spending Accounts (FSAs) or Health Savings Account (HSA).
Vision and dental coverage.
Voluntary options for long-term disability, accident, critical illness, and hospital indemnity.
Discounts for pet care.
Employer-paid short-term disability and life insurance.
Flexible PTO, generous paid holidays, and Flex Time options.

Senior Validation Engineer

Key skills