Senior MES/eBR Specialist - cGMP, CSV & Validation

Automatic Data Processing, Inc.; Carolina (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

JC Automation Corp. (JCA) seeks a technically experienced MES Support professional with deep expertise in Electronic Batch Record (eBR) systems in a cGMP pharmaceutical environment. You will serve as SME for eBR design, configuration, troubleshooting, and validation.

Collaborate with Manufacturing, Quality, IT, and Engineering to maintain validated eBR environments, implement configurations, support capital projects, and ensure MES activities comply with cGMP and Data Integrity standards.

Qualifications

• Bachelor's degree in engineering, information technology, or life sciences.
• 3–5 years of MES/eBR support in GMP pharma/biotech.
• Experience with eBR configuration, programming, and validation.
• Knowledge of cGMP, 21 CFR Part 11, and Data Integrity for electronic systems.
• Bilingual in English and Spanish (oral and written).

Responsibilities

• CSV execution and change control for eBR systems.
• Troubleshoot and resolve MES eBR issues.
• Develop and deploy eBR templates, workflows, and forms per specs.
• Provide SME support for eBR design and configuration.
• Evaluate current eBR workflows and suggest improvements.
• Develop and revise eBR documentation in the DMS, including security plans and disaster recovery.
• Communicate effectively with cross‑functional teams to meet project milestones.

Skills

eBR systems

CSV validation

Regulatory compliance

DMS

MS Office 365

Education

Bachelor's degree in Engineering or IT

Tools

Syncade MES

DeltaV

Kepware

PMX

Kneat

Job description

JC Automation Corp. (JCA) seeks a technically experienced MES Support professional with deep expertise in Electronic Batch Record (eBR) systems in a cGMP pharmaceutical environment. You will serve as SME for eBR design, configuration, troubleshooting, and validation.

Collaborate with Manufacturing, Quality, IT, and Engineering to maintain validated eBR environments, implement configurations, support capital projects, and ensure MES activities comply with cGMP and Data Integrity standards.