MES Functional Consulting

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.
• Cook up and execute validation documentation supporting MES/EBR implementations including IQ/OQ and related validation activities.
• 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.