POMS MES Techno-Functional SME

🕒 Agosto 12

🗽 New York – Remoto

infoinfo

💵 $73.000 - $174.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

🎁 Marketing de Produto

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Capgemini

10.000+ funcionários

Fundada em 1967

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

A Capgemini é líder global em parceria com empresas para transformar e gerenciar suas operações aproveitando o poder da tecnologia. Com expertise em uma ampla gama de setores, como aeroespacial, automotivo, bancário e saúde, a Capgemini oferece um portfólio de serviços em constante evolução para atender às necessidades, em constante mudança, de seus clientes. Suas ofertas incluem Cloud, cibersegurança, dados e inteligência artificial (IA), e gestão empresarial, entre outras. A Capgemini também enfatiza inovação e sustentabilidade, ajudando as empresas a alcançar a transformação digital enquanto promove a responsabilidade ambiental e social. Além disso, a Capgemini oferece oportunidades de carreira em diversos níveis e profissões, incentivando a inovação e a diversidade em sua força de trabalho.

Descrição

• Collaborate with Manufacturing, Quality, Validation, and IT stakeholders to gather, analyze, and document business requirements • Translate business requirements into MES functional specifications, solution designs, and implementation strategies • Lead requirements workshops, discovery sessions, fit-gap analyses, design reviews, and user acceptance testing • Optimize production workflows and leverage POMS MES capabilities to improve operational performance • Align MES solutions with manufacturing processes, business objectives, and regulatory requirements • Support process harmonization across manufacturing sites • Configure, support, and enhance POMS MES workflows, electronic batch records, recipes, and manufacturing execution processes • Troubleshoot MES modules and resolve production support issues through root cause analysis and corrective actions • Support and review MES integrations with ERP, LIMS, Historians, Automation/SCADA, and other manufacturing applications • Review technical specifications, configuration documentation, and implementation deliverables • Assist with deployments, upgrades, migrations, and release management • Provide expertise in electronic batch record execution, deviations management, manufacturing investigations, and exception handling • Support Computer System Validation activities throughout the system lifecycle • Author, review, and maintain validation documentation including URS, FRS, DS, IQ, OQ, PQ, and VSR • Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GMP

🎯 Requisitos

• Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related field • 8–12 years of experience in Life Sciences, Pharmaceutical, or Biotech manufacturing environments • 5+ years of hands-on experience supporting or implementing POMS MES solutions • Strong understanding of MES concepts, electronic batch records, batch execution, manufacturing operations, and production workflows • Experience working in GxP-regulated environments • Solid understanding of pharmaceutical manufacturing processes, validation methodologies, and quality systems • Experience supporting MES implementations, enhancements, upgrades, and production support activities • Ability to review and interpret functional and technical documentation • Strong troubleshooting and analytical problem-solving skills • Preferred: experience with large-scale MES implementation or site rollout programs • Preferred: exposure to ERP, LIMS, Historian, SCADA, or automation platform integrations • Preferred: knowledge of ISA-95 manufacturing standards and digital manufacturing architectures • Preferred: experience supporting global manufacturing organizations

🏖️ Benefícios

• Variable incentives, bonuses, or commissions may be available depending on the position and applicable laws • Paid time off: vacation (12–25 days depending on grade), company paid holidays, personal days, and sick leave • Medical, dental, and vision coverage • Retirement savings plans (e.g., 401(k) in the U.S.) • Life and disability insurance • Employee assistance programs • Other benefits as provided by local policy and eligibility

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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