For Validation services in the Engineering area. WHAT MAKES YOU A FIT: 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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Associate Engineer • Arecibo, PR, PR
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