Senior Computer Systems Validation Engineer

Work location: Trumbull, CT (on-site)

The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role establishes and maintains the corporate CSV framework, oversees critical programs and complex enterprise systems, ensures regulatory inspection readiness, and drives a risk‑based, inspection‑ready validation culture across the organization.

• Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high‑risk programs throughout the systems life cycle.
• Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA.
• Lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems).
• Drive inspection readiness and continuous improvement in the CSV team.
• Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology.
• Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV.
• Provide guidance with functional/end user requirements, compliance, and system specifications, ensuring proper documentation for operational excellence.
• Provide test execution training and assist teams with discrepancy management.
• Support process owners for quality management systems and associated policies, procedures, and work instructions.
• Oversee requirements traceability matrices for completeness of documentation and testing for user‑specific requirements; review and identify critical issues.
• Ensure compliance with internal and external computer system lifecycle policies and regulations.
• Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance.
• Ensure issues are identified, tracked, reported, and resolved in a timely manner.
• Perform other duties as assigned.

• Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems.
• Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies.
• Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports.
• Experience and knowledge of various QMSs, Agile PLM, Master Control, Veeva, Track Wise, or equivalent system.
• Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971.
• Ability to engage and collaborate with cross-functional teams, including IT, Quality Assurance, Validation, and business project stakeholders.
• Knowledge of business enterprise functions and processes. Experienced in organizing meetings.
• Strong analytical and problem‑solving skills with ability to identify issues, evaluate options, and implement effective solutions.
• Ability to adapt to a fast and dynamic environment and effectively engage with various 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 skills.
• Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments.
• Ability to work independently and within teams; self‑motivated, self‑directed, and detail oriented.
• Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat.
• Experience/knowledge of Agile PLM, Master Control, IQVIA, or equivalent QMS system.
• Experience/knowledge of Waterfall, Agile, or Hybrid software development.
• Experience/knowledge of automated systems for following activities/functions preferred:
• Enterprise Resource Planning (Oracle E Business Suite)
• Document management (SharePoint)
• Requirements and Testing (JIRA/Azure Dev Ops/HP…