Process Engineer
For Validation services in the Facilities area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s degree in Engineering and a minimum of five (5) years of exposure in Validation activities within the Pharmaceutical or Medical Device Industry.
- Excellent verbal/written communication skills (English and Spanish)
- Shift: Administrative & according to business needs
- Softwares: MS Office (Word, Excel, PowerPoint), Maximo
- Experience in:
- Validation Life Cycle (IQ, OQ, PQ, CSV, FAT)
- Facilities area
- 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)
- Improve processes through preventive and corrective actions as part of Non-conformance and CAPA (Corrective and Preventive Actions) management.
- Investigate Non-conformances and CAPAs related to process, product, and facility performance to identify root causes and implement solutions.
- Write Validation Plans, IQ/OQ Protocols, IQ/OQ Reports, Design Qualification, User
- Requirements, and other necessary documentation to validate production equipment, enhance throughput, improve equipment performance, and ensure business continuity.
- Coordinate the repair and installation of equipment to ensure seamless manufacturing operations and continuous production flow.
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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