Validation Engineer
For Validation Engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Engineering or related field and at least three (3) years of previous exposure Leading/Executing Validation activities within the regulated industry.
- Bilingual: (Spanish and English)
- Shift: Administrative & according to business needs
- Experience in:
- Validations/Qualifications
- Change Control
- 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)
- Develop extrusion validation documentation such as protocols, technical summaries, reports, standard operating procedures, etc.
- Coordinate and work with the corresponding functional areas to assure timely validation activities execution.
- Execution of validation protocols, feasibility studies, metrology, asset induction, data collection, etc.
- Timely submission and management of BD APM' Product Lifescycle Management System for changes on drawings, part, structures, documents, protocols, and risk management.
- Completion of applicable change control documentation, VRBs, CRs/CNs, Trainings, etc.
- Follow up on changes in all the stages to assure timely completion aligned with project timeline expectations.
- Aid in the investigation and implementation of related nonconformities and CAPAs activities.
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?