MES Lead - eBR & CSV Expert for GMP/Regulated Ops

JC Automation; Carolina (PR); Presencial; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

JC Automation Corp. seeks an MES Support professional with deep eBR expertise in a cGMP pharma setting. You will design, configure, troubleshoot, and validate eBR systems, collaborating with Manufacturing, Quality, IT, and Engineering to maintain validated environments.

You will support CSV activities, develop new templates, and ensure data integrity while aligning with regulatory requirements. Strong English/Spanish communication is required.

Qualificações

• Bachelor's degree in Engineering, IT, or Life Sciences required.
• 3–5 years of MES/eBR support in GMP environments.
• Experience with Syncade MES or equivalent platform.
• Knowledge of cGMP, 21 CFR Part 11, and Data Integrity.

Responsabilidades

• CSV Execution: Support CSV activities and close change control for eBR.
• eBR Troubleshooting: Troubleshoot and resolve MES eBR issues.
• eBR Development: Develop/configure new eBR templates and forms.
• Subject Matter Expertise: SME support in eBR design and programming.
• System Evaluation: Evaluate workflows; recommend improvements for compliance.
• Documentation & Training: Revise eBR docs in DMS; support data integrity.
• Communication: Collaborate with cross-functional teams to meet deliverables.

Conhecimentos

eBR system expertise

CSV/validation

GMP compliance

Syncade MES

Regulatory documentation

Spanish bilingual

Cross-functional collaboration

Formação académica

Bachelor's degree in Engineering or Life Sciences

Ferramentas

Syncade MES

DeltaV

Kepware

PMX

Kneat

DMS

Office 365

Descrição da oferta de emprego

JC Automation Corp. seeks an MES Support professional with deep eBR expertise in a cGMP pharma setting. You will design, configure, troubleshoot, and validate eBR systems, collaborating with Manufacturing, Quality, IT, and Engineering to maintain validated environments.

You will support CSV activities, develop new templates, and ensure data integrity while aligning with regulatory requirements. Strong English/Spanish communication is required.