MES Support Specialist

For MES services in the Business Technology area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree and five (5) years of experience or more 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 clients' 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?