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Because people with diabetes should have the freedom to live the life they want.
Staff Validation Engineer
Location
New Hampshire
Posted
91 days ago
Salary
$165K - $175K / year
Seniority
Lead
Job Description
Staff Validation Engineer
Sequel Med Tech
• 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
Job 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
Benefits
- 401k plan with 6% company match
- Immediate vesting
- Capped out-of-pocket insulin costs
- GLP-1 coverage across all plans
- Meritain health insurance plans
- Flexible Spending Accounts (FSAs)
- Health Savings Account (HSA)
- Vision and dental coverage
- Voluntary long-term disability coverage
- Accident insurance
- Critical illness insurance
- Hospital indemnity
- Discounts for pet care
- Employer-paid short-term disability
- Employer-paid life insurance
- Flexible PTO
- Generous paid holidays
- Flex Time options
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