MES Support Specialist

For MES services in the Business Technology area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelors Degree andthree(3) years of experiencewithin 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:
  • Technicaltransfer 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 other words being a customer service pro is one your (many) talents. Being the Piece means youre 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 inaccordance withmanufacturing 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 alterationsor 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 inplanning recommending and implementingMES 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 clientsprocedures.
• 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 clientleads regarding projects and assigned activities.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece