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What is the role of a MES Lead at JC Automation Corp?

The MES Lead position at JC Automation Corp is a Full-time or part-time position opportunity in the Admin/Clerical/Secretarial field.

Where is this MES Lead job located?

Carolina, Other / Non-US, 00981, Puerto Rico

What type of employment is offered for this MES Lead role?

Full-time or part-time position

What is the expected salary for this MES Lead job?

Compensation will be discussed during the hiring process.

MES Lead job near me in Carolina, Other / Non-US at JC Automation Corp

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

We are looking for a technically experienced MES Support professional with deep expertise in Electronic Batch Record (eBR) systems. In this role, you will serve as the subject matter expert for eBR system design, configuration, troubleshooting, and validation within a cGMP-regulated pharmaceutical manufacturing environment.

You will collaborate with Manufacturing, Quality, IT, and Engineering teams to maintain validated eBR environments, implement new configurations, support capital projects, and ensure all MES activities comply with cGMP standards and Data Integrity requirements.

RESPONSIBILITIES

CSV Execution: Support Computer System Validation (CSV) activities and evaluate and close change control documentation for eBR systems.
eBR Troubleshooting: Perform troubleshooting, debugging, and issue resolution for MES eBR applications and related computerized systems.
eBR Development: Develop, configure, and deploy new electronic batch record templates, workflows, and forms per manufacturing and regulatory specifications.
Subject Matter Expertise: Provide SME support in eBR system design, configuration, and programming for ongoing operations, technical transfers, and capital projects.
System Evaluation: Evaluate current EBR workflows, configurations, and functionalities; identify limitations and recommend design or process improvements aligned with compliance requirements.
Documentation & Training: Develop and revise eBR documentation in the DMS; including and nonlimited to Security Plans, Business Contuinty Plan, Disaster Recovery. Support documentation, compliance, and data integrity activities within regulated environments.
Effectively communicate and collaborate with cross-functional teams to ensure timely completion of project deliverables.

REQUIREMENTS & QUALIFICATIONS

Required

Bachelor's degree in Engineering (Computer, Electrical, Chemical), Information Technology, or Life Sciences.
Minimum 3–5 years of experience supporting MES or eBR systems in a GMP pharmaceutical or biotech environment.
Demonstrated expertise in eBR system configuration, programming, and validation.
Experience with Syncade MES or an equivalent platform.
Knowledge of cGMP, 21 CFR Part 11, and Data Integrity requirements for electronic systems.
Bilingual in English and Spanish (oral and written).

Preferred

Experience executing CSV lifecycle documentation for MES systems.
Knowledge of backup/restore validation and disaster recovery for GMP systems.

SKILLS

Technical Skills

MES eBR systems — Syncade or equivalent (configuration, programming, validation)
Computer System Validation (CSV) for MES systems
cGMP, 21 CFR Part 11, and Data Integrity compliance
Document Management Systems (DMS)
Microsoft Office 365 — Word, Excel, Project, Teams
DeltaV (highly desired)
Kepware (preferred / nice to have)
PMX (preferred / nice to have)
Kneat

Soft Skills

Deep technical credibility as an eBR subject matter expert
Clear communication with Manufacturing, IT, Quality, and Engineering stakeholders
Strong project ownership and milestone accountability
Proactive problem solving and risk escalation
Disciplined in compliance documentation
Ability to work independently and manage multiple priorities
Strong stakeholder management and communication skills

MES Lead in Carolina at JC Automation Corp

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