As part of the Hillsboro IT OT team, you will serve as the <\/span>System Owner / Local Product Owner<\/b> <\/span>for the Manufacturing Execution System (MES – Rockwell PharmaSuite) in a 24x7 GMP pharmaceutical manufacturing environment. You will ensure robust system lifecycle management, GMP compliance, and support for product transfers, while contributing to global IT OT standardization and optimization.<\/span>
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Own and manage the MES system lifecycle: design, integration, maintenance, validation, and retirement.
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Ensure GMP compliance for system changes, upgrades, and integrations (SAP, LIMS, EDMS, etc.).
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Partner with business stakeholders to improve processes and enable standardized technologies across sites.
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Define business criticality and product quality requirements, ensuring governance, compliance, and disaster recovery.
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Lead vendor discussions, technical evaluations, and Agile -based delivery initiatives.
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Support regulatory audits and inspection readiness.
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Bachelor’s degree in Informatics, Engineering, or related field.
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5+ years of experience with <\/span>Manufacturing Systems<\/b> <\/span>(preferably Rockwell PharmaSuite).
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Strong background in <\/span>bio -pharmaceutical or life sciences manufacturing<\/b>.
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Proficiency in MES, ERP, LIMS, PI Data Historian, and Quality Systems (Veeva, ValGenesis).
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Experience with SQL Server, scripting, troubleshooting, and batch management.
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Solid understanding of <\/span>GMP, FDA 21 CFR Part 11, cGMP Annex 11, and data integrity principles<\/b>.
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Strong collaboration, vendor management, and Agile leadership skills.
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Willingness to support 24x7 on -call operations, including weekends/holidays.
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hr@dawarconsulting.com
kavitha@dawarconsulting.com