Quality Engineer - CSV
For Quality services in the Engineering and Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Life Sciences, Engineering, or related field and at least three (3) years of previous exposure to Computer System Validation protocols activities within the regulated industry.
- Bilingual: (Spanish and English)
- Shift: Administrative & according to business needs
- Experience in:
- Validation Life Cycle (IQ, OQ, PQ), CSV documentation
- QA Review
- GMP & GDP regulations
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)
- Generate CSV periodic reviews following site template.
- Conduct the evaluation of data collected and determine any gaps against SOPs.
- Generate periodic review reports and present results to the validation review board.
- Use the Agile document management system to route and approve documents/reports.
- Provide CSV support if needed in other projects.
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?