What are the responsibilities and job description for the MES Functional Consulting position at Katalyst CRO?
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.
- 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.
- 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.