MES Functional Consulting

Katalyst CRO; Indianapolis (IN); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO in Indianapolis, IN seeks an MES Functional Consultant to advance Manufacturing Execution System initiatives in pharmaceutical/biotech environments.

You will participate in fit-gap analysis, process modeling, EBR configuration, and validation (IQ/OQ), troubleshoot PharmaSuite MES issues, and provide HyperCare and go‑live support, collaborating with cross‑functional teams to deliver compliant MES solutions.

Qualifications

• Bachelor's degree in Engineering, IT, Biotechnology, or related field.
• Experience with MES, preferably PharmaSuite MES.
• Understanding of pharmaceutical/biotech manufacturing processes.
• Experience configuring EBRs and conducting MES validation.

Responsibilities

• Participate in fit-gap analysis sessions and process modeling.
• Configure and maintain Electronic Batch Records (EBRs).
• Develop and execute IQ/OQ validation documentation.
• Troubleshoot PharmaSuite MES issues and support go-live/hypercare.

Skills

Fit-gap analysis

Process modeling

IQ/OQ validation

Troubleshooting

Cross-functional collaboration

User requirements gathering

Education

Bachelor's degree in Engineering or IT

Tools

PharmaSuite MES

Electronic Batch Records (EBR)

Job description

• 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.

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

• 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.

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.