MES Lead Digital Manufacturing
4 days ago
A leader in Life Science Manufacturing Technology Solutions, we are looking for top talent to join our dynamic team and contribute to our continued growth journey.
About the Role
We are looking for an experienced MES Project Leader to drive end-to-end MES implementations and support our digital manufacturing roadmap. This role acts as the key bridge between business users and technical teams, ensuring robust, compliant, and efficient MES solutions.
Key Responsibilities
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Lead full lifecycle MES projects requirements, design, testing, deployment, and hypercare.
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Gather and translate user requirements into functional specifications.
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Drive business process mapping for manufacturing workflows (batch, material, quality).
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Coordinate with Manufacturing, Quality, Engineering, MSAT, and Digital teams.
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Oversee UAT, system configuration reviews, and integration with ERP/DeltaV/Historians.
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Ensure compliance with GMP, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+).
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Manage project timelines, risks, documentation, and stakeholder communication.
What You Bring
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10+ years experience in MES implementation within Pharma/Biotech.
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Strong hands-on exposure to Siemens OpCenter / PAS-X / similar MES platforms.
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Solid understanding of GMP manufacturing, batch execution, and shop-floor processes.
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Experience in requirements gathering, UAT coordination, and CSV validation.
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Strong stakeholder management and communication skills.
Nice to Have
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Experience with multi-site/global MES rollouts.
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Knowledge of ISA-95, industry 4.0 concepts, and enterprise system integrations.
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PMP or equivalent certification.
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