Senior Validation Specialist – Watson/LIMS

🕒 Setembro 15

🔔 Pennsylvania – Remoto

🔔 Pennsylvania – Remote

⏰ Tempo Integral

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Implement, configure, maintain, troubleshoot, and support Thermo Scientific LIMS products • Provide technical expertise for LIMS products and computer system validation • Develop and execute validation documentation, including requirements, risk assessments, test protocols/scripts, traceability matrices, validation reports, and associated evidence • Perform functional, regression, integration, and user-acceptance testing • Document test results and investigate test failures and deviations • Ensure systems and documentation meet applicable GxP/GLP and data-integrity requirements • Assess system changes, enhancements, upgrades, and defects for validation impact • Coordinate appropriate testing for system changes • Maintain controlled validation records, specifications, test scripts, and lifecycle documentation • Work with laboratory scientists, QA, IT, developers, project managers, and business stakeholders to translate laboratory requirements into validated solutions • Lead implementation and validation activities • Review other analysts' work and resolve complex issues • Provide subject-matter expertise • Support audits and inspections • Interact frequently with clients and travel during key project phases as needed

🎯 Requisitos

• Advanced Degree plus 4+ years of experience, or bachelor's degree plus 5+ years of LIMS experience • Experience with Thermo Fisher SampleManager and/or Watson LIMS platform • Experience in pharma, biotech, CRO, or regulated laboratory environments • Demonstrated experience supporting system implementations and validations • Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 • Hands-on experience authoring and executing IQ/OQ/PQ and related validation documentation • Experience working directly with clients in a consulting, vendor, or services capacity • Strong understanding of SDLC and system implementation methodologies • Excellent communication skills and ability to manage client expectations and present clearly • Strong client-facing and consulting skills • Ability to translate technical and regulatory concepts into practical solutions • Project ownership and accountability for deliverables • Problem-solving in fast-paced implementation environments • Collaboration across cross-functional delivery teams • Detail-oriented with a strong compliance mindset • Familiarity with Agile or hybrid delivery models • Experience with validation tools, test management systems, or ITSM platforms • Prior experience in a professional services or consulting organization • Ability to manage multiple priorities in a project-driven environment • Ability to travel

🏖️ Benefícios

• Fully remote work arrangement • Standard Monday–Friday work schedule • Meaningful work contributing to global health, environmental, food safety, and cancer research initiatives • Opportunities to support audits and inspections • Professional services and consulting experience