Project/Validation Engineer
Arecibo, PR, Puerto Rico
Contracted
Medical Device
Experienced
For Validation services in the Engineering area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s Degree and or an equivalent of three (3) years of experience in Industrial and Construction projects within the regulated industry.
- Bilingual (Spanish and English).
- Good organizational and problem-solving skills.
- Shift: First (Monday-Friday) & according to business needs.
- Experience in:
- Process Validation and Development.
- FDA, GMP, and ISO guidelines.
- Statistical techniques (DOE, SPC).
- Computer software knowledge (Microsoft Word, Excel, Power Point).
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 of 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 Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Develops, manages, and executes cost improvement, product/process, and technology transfer projects.
- Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
- Generate and execute validation protocols (IQ, OQ, PQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
- Conduct process equipment installation/operational/performance qualification studies to test their functionality .
- Support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.
- Other duties as assigned.
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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