CSV Specialist

 For Validation services in the Engineering area

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's Degree in Life Sciences or Engineering and at least three (3) years of previous exposure in Validation activities within the Pharmaceutical or Medical Devices industry. 
• Bilingual, Spanish and English (good communications)
• Shift: Administrative & according to business needs 
• Experience in:
  • Validation Life Cycle (CSV) 
  • Automation & Control Systems 
  • GMP & GDP 

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)

• Ensure design specification, qualification, and change control documentation is current, controlled, and approved to meet quality, information security, and safety requirements. 
• Build and complete validation plans, system test scripts, protocols, and reports, while maintaining appropriate traceability of records
• Ensure timely, thorough, and complete execution of all protocols, meeting FDA requirements.
• Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
• Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
• Ensures complete and thorough investigation of all product failures and deviations associated with validation sampling and testing.

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?