POMS MES Techno-Functional SME

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🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $73k - $174k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🎁 Product Marketing

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Capgemini

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1967

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Capgemini is a global leader in partnering with businesses to transform and manage their operations by harnessing the power of technology. With expertise across a wide array of industries such as aerospace, automotive, banking, and healthcare, Capgemini provides a constantly evolving portfolio of services to meet the ever-changing needs of their clients. Their offerings include cloud, cybersecurity, data and artificial intelligence, and enterprise management, among others. Capgemini also emphasizes innovation and sustainability, helping companies achieve digital transformation while promoting environmental and social responsibility. Additionally, Capgemini provides career opportunities across various levels and professions, encouraging innovation and diversity in its workforce.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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