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Sequel Med Tech · 6 hours ago

Senior Validation Engineer

Marlborough, MA

Full-time

Onsite

Senior Level

$165K/yr - $195K/yr

6+ years exp

Sequel Med Tech is a company focused on transformative drug-delivery advancements for diabetes management. The Senior Validation Engineer will develop, execute, and maintain validation deliverables to ensure compliance with regulatory requirements while collaborating with cross-functional teams to support validation activities throughout the system lifecycle.

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

Computer System ValidationAutomated TestingValidation DeliverablesSalesforce ValidationTest Automation ToolsCI/CD PipelinesRisk AssessmentEffective CommunicationCross-Functional CollaborationAttention to Detail

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

Experience with test case development, automated & functional testing according to requirements and test plans with attention to detail

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

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 automation tools and frameworks