CooperSurgical · 2 weeks ago
Junior Computer Systems Validation Engineer
Trumbull, CT
Full-time
Hybrid
Entry Level
2+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. The Junior Computer Systems Validation Engineer will assist in developing and executing validation protocols for computer systems and collaborate with cross-functional teams to troubleshoot and resolve validation issues.
Health CareMedical DeviceWomen's
Responsibilities
Maintains computer system inventory listing of all computer systems inventory. Review release notes and perform periodic reviews of validated systems
Assist in developing and executing validation protocols (IQ/OQ/PQ) for computer systems and related software
Support Risk Assessments for system changes
Collaborate with cross-functional teams (Quality Assurance, IT, and Manufacturing) to troubleshoot and resolve validation issues
Maintain validation documentation in accordance with company SOPs and regulatory guidelines. Validation documentation includes validation plans, user and system requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports
Routes documents for review and approval
Maintains validation templates
Ability to work on project teams for Software Development Life Cycle phases
Performs periodic reviews and supports remediation activities on validated systems
Provides test execution training and assists teams with deviation management
Ensures validation issues are identified, tracked, reported on, and resolved in a timely manner
Perform other duties as assigned
Qualification
Required
Experience in Computer Systems Validation, Software Quality Assurance of Quality Management Systems
Familiar with Systems Development Lifecycle Management (SDLC) and Change Management methodologies
Familiar with computer systems used in support of GxP operations
Knowledge of regulatory requirements including FDA 21 CFR Parts 11, 58, 211, 820, and 1271; SOX, GAMP, ISO 13485, and ISO 14971 with a basic understanding of GxP processes, risk-based approaches, and validation principles
Ability to effectively engage and collaborate with cross-functional teams, including IT, Quality Assurance, Validation, and business project stakeholders
Knowledge of the business enterprise functions and processes
Strong analytical and problem-solving skills with the ability to identify issues, evaluate options, and implement effective solutions
Ability to effectively engage functional and technical teams
Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency
Strong written, verbal, and interpersonal communication abilities
Effective time management with proven adaptability to shifting priorities, resource changes, and scheduling adjustments
Demonstrates the ability to work independently and within teams; self-motivated, self-directed, and detail oriented. Experience working in a team-oriented, collaborative environment
Ability to communicate effectively with management and in team environments
2+ years of experience in assigned function's business process and supporting systems
2+ years of experience in a QA or IT Compliance department
Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat
Experience or knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system
Experience with Waterfall, Agile, or Hybrid software development
Experience with automated systems for following activities/functions is beneficial: Enterprise Resource Planning (Oracle E Business Suite), Document management (SharePoint), Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC), Change/Incident Management (ServiceNow), Project/Task Management (Smartsheet/Excel spreadsheets)
Bachelor of Science Degree, Computer Engineering, or relevant science field required
2+ years in the Computer Systems Validation field
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation
Personal, sick and holidays
Multiple other perks and benefits
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
1001-5000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
MarketScreener
2025-08-29
2025-08-27
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