CSV 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:
  • MES platforms (Emerson Syncade, including development and maintenance of BI solutions).
  • ​​Computer systems integration and validation experience.
  • Authoring and executing validation documentation (test scripts, protocols, reports). 

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)

• Supporting Syncade recipe configuration and maintenance, version control, and lifecycle management (e.g., Recipe Authoring, Equipment Tracking, Material Management, Workflow, Inventory)
• Configure and maintain MES modules and workflows, ensuring alignment with site and global standards.
• Configure and support MES integrations with ERP and automation systems (e.g., SAP, DCS, middleware).
• Provide configuration-level troubleshooting and support, as well as root cause analysis, for MES-related issues.
• Execute and support CSV deliverables associated with Syncade configuration changes, including but not limited to: Risk assessments, URS / FRS reviews, test plans and test scripts, and IQ / OQ / PQ execution and summary reports.
• Prepare and ensure validation documentation complies with GMP, CSV, and ALCOA+ data integrity principles.
• Support change control impact assessments, deviations, and CAPA activities related to MES.
• Support data validation and reconciliation activities for MES-related reports.
• Collaborate with cross-functional stakeholders to ensure solutions meet business and compliance needs.
• Participate in project meetings, design reviews, and deployment activities.
• Comply with all site training, validation, data integrity, and safety requirements.

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?