Senior Validation Engineer

Job Description

Job Description

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.

Job Overview

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.

Job Responsibilities and Essential Duties

• 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.

Minimum Requirements

Required Knowledge, Skills and Abilities

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, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

At Sequel, we believe that when you thrive, we thrive. That’s why we’ve designed a benefits package that’s as thoughtful as it is generous. From day one, you’re automatically enrolled in our 401k plan—no waiting, no worries—with a 6% company match and 100% immediate vesting. We prioritize your well-being, especially for our employees and their families living with diabetes, with capped out-of-pocket insulin costs and GLP-1 coverage across all plans. With multiple medical plans through Aetna, including a 100% company-paid high deductible plan paired with employer HSA contributions, you can select what suits your needs. Additional benefits include vision and dental plans, employer-paid short-term disability, and voluntary options like accident and pet insurance.

Need time to relax and recharge? You’ll enjoy flexible PTO and generous paid holidays, all while being part of a culture that values hard work, fun, and support. We don’t just offer jobs—we offer careers that build futures. Join us, and let’s grow together!

Environmental / Safety / Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions

Use of computer and telephone equipment and other related office accessories / devices to complete assignments

May work extended hours during peak business cycles

Physical requirements such as lifting specific weights

Some travelling is expected