MES Functional Consulting
Katalyst HealthCares & Life Sciences
Job-ID32350347Reference26-00792 Job Summary:The MES Functional Consultant will support Manufacturing Execution System (MES) initiatives within pharmaceutical/biotech manufacturing environments. The role involves participating in fit-gap analysis, process modeling, Electronic Batch Record (EBR) configuration, validation activities, troubleshooting PharmaSuite MES issues, and supporting go-live/hypercare activities. The consultant will collaborate with cross-functional teams, business stakeholders, process SMEs, and technical teams to deliver compliant and efficient MES solutions aligned with manufacturing and IT standards.Roles & Responsibilities:Participate in fit-gap analysis sessions, process modeling, and process standardization activities with business stakeholders and process SMEs.Collaborate with lead business analysts and requirement analysts to develop business and functional requirements.Provide effort estimations, user story point estimations, and status updates for assigned tasks and deliverables.Configure and maintain Electronic Batch Records (EBRs) in Development, Stage, and Production environments.Author, review, and execute validation documentation supporting MES/EBR implementations including IQ/OQ and related validation activities.Troubleshoot and resolve issues related to PharmaSuite MES and associated manufacturing systems.Work closely with site teams to address site-specific use cases, enhancement requests (ERs), and operational requirements.Coordinate across functional and technical teams to gather requirements and support EBR development activities.Provide HyperCare and Go-Live support during MES deployments and production rollouts.Ensure compliance with IT lifecycle management processes, IT business process models, and ISA/S95 standards.Support continuous improvement initiatives related to MES processes and manufacturing operations.Communicate effectively with global teams, business users, and technical stakeholders.Education & Experience:Bachelor's degree in Engineering, Information Technology, Computer Science, Biotechnology, Pharmaceutical Sciences, or related field.Experience working with Manufacturing Execution Systems (MES), preferably PharmaSuite MES.Strong understanding of pharmaceutical or biotech manufacturing processes and manufacturing systems.Experience with Electronic Batch Record (EBR) configuration and MES validation activities.Knowledge of IT lifecycle management, IT business process models, and ISA/S95 standards.Hands-on experience in troubleshooting and resolving MES-related production/support issues.Experience developing and executing IQ/OQ and validation documentation.Strong analytical, problem-solving, and process improvement skills.Excellent verbal and written communication skills.Ability to work in cross-functional and fast-paced project environments.
$91.1k - $179.5k
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