Staff Validation Engineer

Sequel Med Tech • Manchester, NH

8d

About The Position

Sequel Med Tech is seeking a Staff Validation Engineer to support our growing portfolio of Enterprise systems. The Staff 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.

Requirements

• 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.

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.

Benefits

• You’ll be automatically enrolled in our 401k plan, featuring a 6% company match and 100% immediate vesting.
• We’re committed to your well-being and understand the unique needs of employees and families living with diabetes, so we offer capped out-of-pocket insulin costs and GLP-1 coverage across all plans.
• You’ll have access to a variety of Meritain health insurance plans to suit your needs and can also take advantage of Flexible Spending Accounts (FSAs) or Health Savings Account (HSA).
• Our comprehensive benefits package includes vision and dental coverage, plus voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and even discounts for pet care.
• In addition, we provide employer-paid short-term disability and life insurance for extra peace of mind.
• That’s why Sequel offers flexible PTO, generous paid holidays, and Flex Time options to help you balance work and life when you need it most.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees