Sequel Med Tech · 1 month ago
Senior Validation Engineer
United States
Full-time
Remote
Senior Level
$165K/yr - $195K/yr
6+ years expSequel Med Tech, headquartered in Manchester, New Hampshire, is dedicated to developing transformative drug-delivery advancements for diabetes management. They are seeking a Senior Validation Engineer to ensure compliance with regulatory requirements by developing and maintaining validation deliverables, collaborating with cross-functional teams, and supporting automated testing efforts.
Health CareInformation TechnologyMedical
Responsibilities
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
Qualification
Required
BS in Computer Science, Software Engineering, or a related field, or equivalent professional experience
6+ years' experience in software industry
3+ years' experience with automated and technical verification
Ability to create and maintain validation deliverables such as validation plans, test plans, test cases, test protocols
Effectively communicate the status and needs of the validation to engineers, product manager, and Quality partners
Broad experience with a range of test approaches and principles, what types of tests to use, when, and a general understanding of how
Familiarity with validating or hands-on experience with systems like Veeva Vault QualityDocs, Veeva QMS, ERP, CRM, AWS, Azure, GitHub, MuleSoft or similar tools
Familiarity with frontend and backend development principles
Familiarity with CI/CD pipelines and DevSecOps processes
Experience with test case development, automated & functional testing according to requirements and test plans with attention to detail
Experience with test automation tools and frameworks
Ability to design, develop and maintain automated test suites
Preferred
Medical device or other regulated industry experience preferred
Experience with Salesforce platform validation and integration would be ideal
Benefits
401k plan with a 6% company match and 100% immediate vesting
Capped out-of-pocket insulin costs
GLP-1 coverage across all plans
Multiple medical plans through Aetna
100% company-paid high deductible plan paired with employer HSA contributions
Vision and dental plans
Employer-paid short-term disability
Voluntary options like accident and pet insurance
Flexible PTO
Generous paid holidays
Company
Sequel Med Tech
We’re Sequel — a driven team of innovators and problem solvers laser-focused on improving the health and lives of people with diabetes.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
William Doyle
Co-Founder and Director
Recent News
2025-09-27
businessweekly.co.uk
2025-09-25
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