Pharma MES Solutions Consultant-Go-Live & Validation

Katalyst CRO; Indianapolis (IN); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Fit-gap analysis

Process modeling

IQ/OQ validation

Troubleshooting

Cross-functional collaboration

User requirements gathering

Educación

Bachelor's degree in Engineering or IT

Herramientas

PharmaSuite MES

Electronic Batch Records (EBR)

Descripción del empleo

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.