For Computer System Validation and Software 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 previous exposure in Computer System Validation activities within the regulated industry.
- Bilingual, Spanish, and English.
- Shift: Administrative & according to business needs
- Experience in:
- Computer System Validation life cycle.
- Protocol development, execution and final report generation
- SAP
- GMP environment
The Personality Part:
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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)
- Write, execute and maintain on a timely basis CSV protocols.
- 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, batch failures and deviations associated with validation sampling and testing.
- Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation 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?
Top Skills
What We Do
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 We The Right Piece For You?
We are:
Experienced and knowledgeable in the Industry
Committed to Safety
Always compliant with FDA Regulations & Audits
Cost Effective
Proven successful track record
Over ten (10) years of experience
If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
