MES Support Specialist

Flexible & Integrated Technical Services • Manati, PR

1d

About The Position

For MES services in the Business Technology area. WHAT MAKES YOU A FIT: The Technical Part: B achelor’s Degree and three (3) years of experience within the Pharmaceutical & Medical Devices Industry. Bilingual: Spanish and English. Soft Skills: Collaborative attitude and Strong communication skills. Shift: Administrative and according to business needs. Experience in: Technical transfer of new drug products through EBR. MES software in a shop floor environment. Programming/Developing for EBRs The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Perform troubleshooting, debugging, and issue resolution for MES eBR applications and related computerized systems. Provide subject matter expertise in eBR system design, configuration, and programming in support of ongoing operations, technical transfers, and capital projects. Evaluate current EBR workflows, configuration, and system functionalities; identify limitations and recommend design, configuration, or process improvements to align with business and compliance requirements. Collaborate with multidisciplinary teams (Manufacturing, Quality, IT, Engineering, etc.) on operational and/or project activities, including providing progress updates on assigned eBR tasks or assessments as needed. Review and evaluate proposed MES eBR design changes to ensure alignment with BMS requirements, cGMP, and data integrity best practices. Participate in the installation, configuration, and qualification of MES eBR modules, including Operating Systems, databases, and required applications. Develop, configure, and deploy new electronic batch record templates, workflows, and forms within the MES platform in accordance with manufacturing and regulatory specifications. Provide status updates on eBR development activities, leveraging project plans to meet milestones and deliverables within pre-established timelines; propose alternatives and solutions to address potential project delays. Coordinate and recommend required actions for additional alterations or changes to eBR functionalities and MES configurations. Coordinate with software vendors and service providers to obtain quotes and facilitate procurement of eBR-related software, licenses, and support services. Assist the engineering and manufacturing teams in planning, recommending, and implementing MES eBR projects or enhancements. Evaluate and close change control documentation, ensuring validated and compliant eBR environments. Assist in the management of Capital Appropriation Requests (CARs) and project timelines for MES EBR system enhancements and new implementations. Support the execution of Computer System Validation (CSV) activities for MES eBR systems and configurations. Develop, update, or revise eBR documentation in the Document Management System (DMS), including procedures for EBR administration, backup/restore, archiving, and maintenance, in accordance with clients' procedures. Provide training and communications to technical and end-user groups to ensure effective implementation and usage of eBR solutions and procedures. Coordinate meetings with technical and cross-functional teams to develop and revise eBR risk assessments. Communicate progress, roadblocks, and unmet requirements to client leads regarding projects and assigned activities. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

Requirements

• Bachelor’s Degree and three (3) years of experience within the Pharmaceutical & Medical Devices Industry.
• Bilingual: Spanish and English.
• Collaborative attitude and Strong communication skills.
• Experience in: Technical transfer of new drug products through EBR.
• MES software in a shop floor environment.
• Programming/Developing for EBRs

Responsibilities

• Perform troubleshooting, debugging, and issue resolution for MES eBR applications and related computerized systems.
• Provide subject matter expertise in eBR system design, configuration, and programming in support of ongoing operations, technical transfers, and capital projects.
• Evaluate current EBR workflows, configuration, and system functionalities; identify limitations and recommend design, configuration, or process improvements to align with business and compliance requirements.
• Collaborate with multidisciplinary teams (Manufacturing, Quality, IT, Engineering, etc.) on operational and/or project activities, including providing progress updates on assigned eBR tasks or assessments as needed.
• Review and evaluate proposed MES eBR design changes to ensure alignment with BMS requirements, cGMP, and data integrity best practices.
• Participate in the installation, configuration, and qualification of MES eBR modules, including Operating Systems, databases, and required applications.
• Develop, configure, and deploy new electronic batch record templates, workflows, and forms within the MES platform in accordance with manufacturing and regulatory specifications.
• Provide status updates on eBR development activities, leveraging project plans to meet milestones and deliverables within pre-established timelines; propose alternatives and solutions to address potential project delays.
• Coordinate and recommend required actions for additional alterations or changes to eBR functionalities and MES configurations.
• Coordinate with software vendors and service providers to obtain quotes and facilitate procurement of eBR-related software, licenses, and support services.
• Assist the engineering and manufacturing teams in planning, recommending, and implementing MES eBR projects or enhancements.
• Evaluate and close change control documentation, ensuring validated and compliant eBR environments.
• Assist in the management of Capital Appropriation Requests (CARs) and project timelines for MES EBR system enhancements and new implementations.
• Support the execution of Computer System Validation (CSV) activities for MES eBR systems and configurations.
• Develop, update, or revise eBR documentation in the Document Management System (DMS), including procedures for EBR administration, backup/restore, archiving, and maintenance, in accordance with clients' procedures.
• Provide training and communications to technical and end-user groups to ensure effective implementation and usage of eBR solutions and procedures.
• Coordinate meetings with technical and cross-functional teams to develop and revise eBR risk assessments.
• Communicate progress, roadblocks, and unmet requirements to client leads regarding projects and assigned activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level