Senior Validation Engineer in Manchester

Energy Jobline ZR; Manchester; On-site; GBP 60,000 - 80,000; Full time

Job summary

A healthcare technology company in Manchester is seeking a Senior Validation Engineer to develop and maintain validation deliverables for regulatory compliance. This role involves collaboration across teams to ensure system integrity and support validation activities, including risk assessments and audits. Ideal candidates have a degree in Computer Science, 6+ years in the software industry, and experience with validation in regulated environments. Join us to contribute to transformative healthcare advancements.

Benefits

401k plan with company match

Medical, vision, and dental plans

Flexible PTO and paid holidays

Employer-paid short-term disability

Qualifications

• 6+ years of experience in the software industry.
• Medical device or regulated industry experience.
• 3+ years experience with automated and technical verification.

Responsibilities

• Develop and maintain validation deliverables.
• Conduct Computer System Validation (CSV) activities.
• Collaborate on change management processes.

Skills

Validation deliverables creation

Effective communication

Test case development

Understanding of test principles

CI/CD pipelines and DevSecOps

Education

BS in Computer Science or related field

Tools

Salesforce

Veeva Vault QualityDocs

AWS

Azure

Job description

Job Overview

Sequel, headquartered in Manchester, New Hampshire, is a company developing transformative drug‑delivery advancements for diabetes. Sequel’s flagship product, the Twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes. 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 and involves collaboration with cross‑functional teams to support validation activities throughout the system lifecycle. The candidate will also serve as the subject matter expert to support our team of full‑stack engineers in developing automated tests and will review and approve delivered features to ensure testing completeness. Experience with both manual and automated testing strategies and effective communication with engineers, product leaders, and quality stakeholders is essential.

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

• BS in Computer Science, Software Engineering, or a related field, or equivalent professional experience.
• 6+ years’ experience in the software industry.
• Medical device or other regulated industry experience.
• 3+ years’ experience with automated and technical verification.

Required Knowledge, Skills and Abilities

• 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, understanding when and what types of tests to use.
• 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 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.

Benefits

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, sex, national origin, genetics, protected veteran status, or other characteristics 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.