For Validation services in the Engineering area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's Degree in Engineering and at least three (3) years of previous exposure to Validation or Quality Engineering activities within the Pharmaceutical or Medical Devices industry. 
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs 
• Experience in:
  • Approving or reviewing change controls, validation plans, IQ/OQ/PQ protocols and Reports and SOPs changes.
  • Writing and reviewing IQ/OQ/PQ protocols and summary reports.
  • Utilities qualification and associated protocols/reports
  • cGMP, FDA regulations, and ISO 13485 requirements

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)

• Review, approve, and manage change controls to assess technical impact, validation status, and regulatory risk.
• Develop, review, and execute validation strategies and plans for equipment, processes, and utilities.
• Author, review, and approve IQ/OQ/PQ protocols and summary reports.
• Review/approve utilities protocols and qualification documentation (e.g., AHU, City Water, Electricity).
• Review and Approve validation-related procedures, work instructions, and templates.
• Support deviation investigations, and risk assessments related to validated systems and processes.
• Collaborate with cross-functional teams to ensure validation deliverables are completed on schedule.

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?