Project Validation Specialist III

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?