Validation Analyst

For Validation Engineering services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least four (4) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry. ,
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • Validations such as: manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, packaging, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required.

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 take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Lead and support the full Computer Systems Validation (CSV) lifecycle for regulated computerized and automation systems.
• Develop and execute validation documentation, including Validation Plans, URS, FRS, SDS, Traceability Matrices, FAT/SAT, IQ/OQ/PQ protocols, and Validation Reports.
• Participate in requirements gathering, risk assessments, protocol development, testing execution, deviation management, and system release activities.
• Review, approve, and maintain validation packages for new and existing computerized, automation, manufacturing, laboratory, utility, and facility systems.
• Investigate, document, and resolve validation deviations, non-conformances, incidents, and CAPA-related activities.
• Analyze validation data and prepare statistical evaluations, trending reports, metrics, and quality system reports.
• Troubleshoot computerized and automated systems during validation activities and recommend corrective actions and process improvements.
• Support installation, qualification, software modifications, and implementation of automated equipment and control systems.
• Ensure compliance with applicable regulations and standards, including FDA, ISO, OSHA, EPA, and company quality procedures.
• Collaborate with cross-functional teams including Manufacturing, Engineering, Quality, Regulatory Affairs, IT, and external vendors to support project execution.
• Lead continuous improvement initiatives focused on validation processes, computerized systems compliance, and operational effectiveness.
• Support internal, corporate, and regulatory audits and contribute to regulatory submissions and inspection readiness 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?