For Software Validation services in the Engineering & Packaging areas.
WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Electrical or Mechanical Engineering and at least four (4) years of previous exposure in Validation activities within the Pharmaceutical or Medical Devices industry. Bilingual, Spanish and English (good communication) Shift: Administrative & according to business needs Experience in: Validation Life Cycle ( CSV ) SCADA 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?
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