Project Validation Specialist

For Project Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT :   The Technical Part : Bachelor’s Degree in Engineering or Science and at least five (5) years of exposure to Validation activities within the Pharmaceutical or Medical Devices industry.  Exposure in Packaging Validations, Design Control, and Product / Process Transfer preferred.  Bilingual (Spanish and English) Shift : Administrative & according to business needs  Experience in : ISO 11607 regulations for sterile barrier packaging.

Shelf-life validation, sterile barrier sealing process validation, and packaging validation.

Packaging and transit (transport) testing and performance test methods.

Package and sealing integrity tests as well as package seal strength tests.

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) Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.

Document Generation – Generate all documentation required, included but not limited to Change Control, Validation Protocols, Drawings, Routers, etc identified as required as part of the project needs.

Validation Executions – Participate in the validation activities (IQ, OQ, PQ, Shipping and Shelf Life, TMV etc.) required to ensure compliance with ISO 11607 as part of the project deliverables.

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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