MES Lead

JC Automation; Carolina (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

eBR system expertise

CSV/validation

GMP compliance

Syncade MES

Regulatory documentation

Spanish bilingual

Cross-functional collaboration

Formation

Bachelor's degree in Engineering or Life Sciences

Outils

Syncade MES

DeltaV

Kepware

PMX

Kneat

DMS

Office 365

Description du poste

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 Contuitiy 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