Senior Computer Systems Validation Engineer

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🔥 0 minutes ago

🦌 Connecticut – Remote

🦌 Connecticut – Remote

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

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CooperCompanies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1978

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 Post-IPO Equity on 2021-12

Healthcare • Consulting • Food & Beverage

CooperCompanies is a global, consumer-centric medical device company that supports how people want to live at every stage of life. The company is dedicated to improving lives by listening closely to healthcare providers and patients to fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment. Their prominent divisions, CooperVision and CooperSurgical, are committed to addressing issues such as myopia in children and supporting families struggling with infertility. CooperCompanies actively engages in sustainable practices and seeks to elevate standards of care with a strong focus on social and environmental impact.

📋 Description

• 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 validation tasks or 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, including testers and business systems analysts, in computer systems lifecycle methodology • Collaborate with IT, manufacturing, quality control, quality assurance, infrastructure, program management, and other teams to provide CSV guidance • Guide functional and end-user requirements, compliance, and system specifications while ensuring documentation is maintained • 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 and review documentation, testing, and critical issues • Ensure compliance with internal and external computer system lifecycle policies and regulations • Communicate with users to identify needs and evaluate alternative business solutions with project, QA Operations, Quality Management, Regulatory, and IT Compliance stakeholders • Ensure issues are identified, tracked, reported, and resolved in a timely manner • Perform other duties as assigned

🎯 Requirements

• 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 computerized systems supporting GxP operations • Experience authoring CSV plans, requirements, risk assessments, test protocols, test reports, traceability matrices, and summary reports • Experience with QMSs, Agile PLM, MasterControl, Veeva, TrackWise, IQVIA, or equivalent systems • Knowledge of CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP; ISO 13485; and ISO 14971 • Ability to collaborate with IT, Regulatory, Quality Assurance, PMO, R&D, project stakeholders, business owners, and system owners • Knowledge of enterprise business functions and processes • Strong analytical and problem-solving skills • Ability to adapt to a fast and dynamic environment • Skill in developing, following, and maintaining procedures and supporting documentation • Strong written, verbal, and interpersonal communication skills • Effective time management and adaptability to shifting priorities, resource changes, and scheduling adjustments • Ability to work independently and within collaborative teams; self-motivated, self-directed, and detail oriented • Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat • Experience with Waterfall, Agile, or Hybrid software development • Experience with automated QMS, ERP, LIMS, ServiceNow, DevOps, JIRA, and project/task management systems preferred • 7+ years of experience in the assigned function’s business process, engineering, and supporting systems for QA and Compliance departments • 5+ years of experience in Computer Systems Validation • Bachelor of Science degree in Computer Engineering or a relevant science field required, or equivalent combination of education and experience • Ability to work in an environment involving prolonged periods of sitting, especially in front of a computer • Ability to follow safety protocols in different manufacturing environments

🏖️ Benefits

• 5–10% domestic and/or foreign travel may be required