Project/validation Engineer

Validation Services Engineer

The Technical Part:

• Bilingual (Spanish and English).
• 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:

• 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?