Senior Validation Engineer

About Sequel

Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug‑delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel’s flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management.

Sequel Med Tech is seeking a Senior Validation Engineer to support our growing portfolio of Enterprise systems. The Senior Validation Engineer is responsible for developing, executing, and maintaining validation deliverables to ensure compliance with regulatory requirements. This role focuses on ensuring systems and processes meet operational and regulatory standards. It involves collaboration with cross‑functional teams to support validation activities throughout the system lifecycle.

You will also serve as the subject matter expert to support our team of full‑stack engineers in developing their automated tests and will review and approve delivered features to ensure testing completeness. The ideal candidate for this role will have experience with both manual and automated testing strategies and will know how to communicate effectively with engineers, product leaders, and Quality stakeholders.

• 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.
• Experience with Salesforce platform validation and integration would be ideal.

• 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

• 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 Salesforce platform validation and integration would be ideal.
• Familiarity with validating or hands‑on experience with systems like Veeva Vault Quality Docs, Veeva QMS, ERP, CRM, AWS, Azure, Git Hub, Mule Soft or similar tools.
• Familiarity with frontend and backend development principles.
• Familiarity with CI/CD pipelines and Dev Sec Ops  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.

$165,000 - $195,000 a year

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color,…