Senior Computer Systems Validation Engineer

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🕒 Agosto 13

🦌 Connecticut – Remoto

🦌 Connecticut – Remote

⏰ Tempo Integral

🟠 Sênior

👷🏻‍♀️ Engenheiro

👻 Score fantasma 22%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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CooperCompanies

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1978

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

💰 Post-IPO Equity em 2021-12

Healthcare • Consulting • Food & Beverage

A CooperCompanies é uma empresa global de dispositivos médicos centrada no consumidor, que apoia o modo como as pessoas querem viver em todas as fases da vida. A empresa é dedicada a melhorar vidas, ouvindo atentamente os profissionais de saúde e pacientes para atender às necessidades de hoje, enquanto se concentra nas oportunidades de amanhã por meio de inovação e investimento estratégico. Suas divisões principais, CooperVision e CooperSurgical, estão comprometidas em abordar questões como miopia em crianças e apoiar famílias que enfrentam dificuldades com infertilidade. A CooperCompanies engaja-se ativamente em práticas sustentáveis e busca elevar os padrões de cuidado com um forte foco no impacto social e ambiental.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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