Engineer

Flexible & Integrated Technical Services, LLC • Añasco, PR

2d

About The Position

For Validation services in the Engineering and Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s degree in Engineering and at least two (2) years of previous exposure to Validation activities within the regulated industry.
Bilingual: (Spanish and English)
Shift: Administrative & according to business needs.
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?
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?

Requirements

• Bachelor’s degree in Engineering and at least two (2) years of previous exposure to Validation activities within the regulated industry.
• Bilingual: (Spanish and English)
• Generation and Execution of Validation Protocols (URS, IQ, OQ, PQ, for Equipment; and/or pFMEA, Test Method)
• GMP & GDP regulations
• Manufacturing equipment

Responsibilities

• Write, execute, and maintain Validation protocols for facility systems and equipment on a timely basis.
• Ensure timely, thorough, and complete execution of all protocols, in compliance with FDA regulations and industry standards.
• Ensure that all new and existing facility validation protocols are effectively integrated into operational processes.
• Ensure documentation is thorough, accurate, and promptly entered into the quality management system.
• Ensure complete and thorough investigation of all facility-related product failures, system failures, and deviations associated with validation sampling and testing.
• Develop documentation of investigations and communicate findings to minimize the risk of recurrence, ensuring that resolutions meet validation requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level