MES Specialist – (eBR) Developer

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative shift (flexible hour based on business needs)

We are seeking an experienced Manufacturing Execution System (MES) Support Specialist / eBR Developer to provide technical and operational support for Electronic Batch Record (eBR) applications within a regulated pharmaceutical manufacturing environment. The selected candidate will support ongoing manufacturing operations, technical transfers, system enhancements, and capital projects through the design, development, configuration, implementation, and maintenance of MES electronic batch record solutions.

Responsibilities

• Develop, configure, maintain, and troubleshoot MES Electronic Batch Records (eBRs), including templates, workflows, forms, and associated system functionalities.
• Provide technical expertise in MES/eBR design, programming, configuration, and implementation to support manufacturing operations, technical transfers, and capital projects.
• Troubleshoot, debug, and resolve MES application issues and related computerized system problems.
• Evaluate existing eBR workflows, configurations, and system functionalities to identify limitations and recommend technical or process improvements.
• Review proposed MES/eBR design changes to ensure compliance with cGMP requirements, Data Integrity principles, and business specifications.
• Collaborate with Manufacturing, Quality Assurance, Engineering, IT, and Automation teams to support system implementations, enhancements, and operational activities.
• Participate in the installation, configuration, integration, and qualification of MES components, including operating systems, databases, and related applications.
• Translate manufacturing process requirements, process diagrams, batch records, and design specifications into functional electronic workflows.
• Coordinate system enhancements, configuration changes, and modifications to existing eBR functionalities.
• Support Change Control activities, including documentation review, implementation, and closure to maintain validated and compliant MES environments.
• Execute and support Computerized System Validation (CSV) activities associated with MES applications and configurations.
• Develop, update, and maintain technical documentation, including system design documents, SOPs, work instructions, and user manuals.
• Support MES system administration, backup and recovery, archiving, maintenance, and operational procedures.
• Assist with project planning, resource coordination, capital project documentation, and implementation timelines.
• Provide technical training and communications to manufacturing personnel, system administrators, and end users.
• Develop and coordinate MES/eBR risk assessments in collaboration with technical and cross-functional teams.
• Monitor project milestones and deliverables, communicate progress and potential roadblocks, and recommend solutions to maintain established schedules.
• Coordinate with software vendors and service providers regarding technical support, software requirements, licensing, and system-related services.

Key Deliverables

• The selected resource will be responsible for developing, implementing, maintaining, and supporting:
• Electronic Batch Record (eBR) templates, workflows, forms, and system configurations.
• MES design specifications, configuration documentation, and technical assessments.
• System troubleshooting, debugging, and issue resolution documentation.
• MES system enhancements, modifications, and Change Control documentation.
• CSV testing and validation support documentation.
• System installation, configuration, integration, and qualification records.
• System administration, backup/restore, archiving, and maintenance SOPs.
• Technical documentation, including work instructions, user manuals, and operating procedures.
• MES/eBR risk assessments and supporting technical documentation.
• Project plans, progress reports, implementation schedules, and milestone updates.
• End-user and technical training materials and supporting records.

Requirements

• Bachelor’s degree in engineering, Computer Science, Information Systems, or a related technical discipline, with a minimum of five (5) years of relevant MES/eBR development and support experience in an industrial or pharmaceutical environment; alternatively, an associate degree with at least eight (8) years of directly related experience.
• Hands-on experience with Manufacturing Execution Systems (MES), particularly Emerson Syncade or equivalent platforms.
• Experience developing, configuring, and supporting Electronic Batch Records (eBRs), including workflows, templates, forms, and scripting.
• Ability to interpret manufacturing process diagrams, batch records, process requirements, and technical specifications and translate them into electronic manufacturing workflows.
• Strong troubleshooting and debugging skills for MES applications and associated IT/Automation systems.
• Knowledge of relational database systems, particularly Microsoft SQL Server.
• Understanding of networking concepts, system integrations, and manufacturing system architecture.
• Experience with MES system administration, backup and recovery processes, and virtualization environments.
• Knowledge of cGMP regulations, pharmaceutical manufacturing requirements, Data Integrity principles, and Good Documentation Practices.
• Experience developing and maintaining SOPs, work instructions, technical specifications, design documents, and user manuals.
• Strong analytical, problem-solving, technical writing, and communication skills.
• Ability to work independently and collaborate effectively with multidisciplinary teams.
• Must complete all required site-specific and corporate training before performing assigned activities.
• Must be available to work on-site and remotely as project requirements dictate.
• Must adhere to established project schedules, quality standards, GMP requirements, and site procedures.

Preferred

• Direct experience with Emerson Syncade Enterprise MES (EMES).
• Experience implementing or enhancing electronic batch record solutions in pharmaceutical or biotechnology manufacturing facilities.
• Familiarity with integration between MES, ERP, LIMS, automation platforms, and other manufacturing applications.
• Knowledge of FDA 21 CFR Part 11, electronic records, electronic signatures, and ALCOA+ Data Integrity principles.
• Experience supporting manufacturing technical transfers and new product introductions.
• Familiarity with Computerized System Validation (CSV) and system lifecycle management.
• Experience coordinating software vendors, technical support providers, and system-related procurement activities.

• Must maintain current training compliance throughout the assignment.
• Must be available to work a regular Monday–Friday schedule, with flexibility for occasional weekend or after-hours support and overtime as required.
• Must establish and maintain defined turnaround times for assigned documents, technical activities, and project deliverables.
• Must communicate project progress, technical challenges, outstanding requirements, and potential schedule impacts to project leadership.