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Sequel Med Tech · 12 hours ago

Staff Validation Engineer

Manchester, NH

Full-time

Onsite

Senior Level, Lead/Staff

6+ years exp

Sequel Med Tech, headquartered in Manchester, New Hampshire, is focused on developing innovative drug-delivery solutions for diabetes management. They are seeking a Staff Validation Engineer to ensure compliance with regulatory requirements and support validation activities across their Enterprise systems.

Health CareInformation TechnologyMedical

Responsibilities

Oversee day-to-day validation activities of the Enterprise Systems

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

Validation deliverablesComputer System ValidationAutomated testingTest case developmentRegulated industry experienceVeeva VaultAWSAzureGitHubDevSecOps processes

Required

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 required

3+ years' experience with automated and technical verification

Ability to create and maintain validation deliverables such as validation plans, test plans, test cases, and 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, Arena, ERP, Salesforce, 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