MES/eBR Lead – GMP Compliance & Validation Expert

JC Automation Corp.

Carolina (PR)

On-site

USD 110,000 - 150,000

Full time

6 days ago

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Job summary

JC Automation Corp. seeks a technically experienced MES Support professional with deep expertise in Electronic Batch Record (eBR) systems.

You will serve as the SME for eBR design, configuration, troubleshooting, and validation within a cGMP pharmaceutical manufacturing environment. You will collaborate with Manufacturing, Quality, IT, and Engineering teams to maintain validated eBR environments, implement configurations, support capital projects, and ensure all MES activities comply with cGMP

Qualifications

Bachelor's degree in Engineering, IT, or Life Sciences.
3–5 years MES/eBR support in GMP pharmaceutical or biotech environments.
Experience with eBR system configuration, programming, and validation.
Experience with Syncade MES or equivalent platform.
Knowledge of cGMP, 21 CFR Part 11, and Data Integrity requirements.
Bilingual in English and Spanish (oral and written).

Responsibilities

CSV execution: support CSV activities and close change control docs for eBR systems.
eBR troubleshooting: troubleshoot, debug, and resolve MES eBR issues.
eBR development: develop and deploy new eBR templates, workflows, and forms.
Subject Matter Expertise: provide SME support in eBR design, configuration, and programming.
System evaluation: review eBR workflows; identify limitations and propose improvements.
Documentation & training: maintain eBR docs in the DMS; ensure data integrity.
Collaborate with cross-functional teams to meet project milestones.