Validation Engineer

For Engineering services in the Manufacturing area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Engineering or related field and at least one (1) year of experience within the Pharmaceutical & Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Excellent communication skills and a positive attitude. 
• Shift: 1st and according to business needs. 
• Experience in:
  •  Process validation and equipment qualification (IQ, OQ, PQ)
  • FDA, ISO 13485, GMP, and quality system requirements
  • CAPAs, NCRs, Change Controls, risk assessments, and root cause investigations

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) 

• Develop and execute validation protocols and reports (IQ, OQ, PQ).
• Support manufacturing by troubleshooting process issues and implementing corrective actions.
• Lead root cause investigations using tools such as 5 Whys, Fishbone, and FMEA.
• Manage and support CAPAs, NCRs, Change Controls, and risk assessments.
• Analyze process data using statistical tools to drive process improvements.
• Ensure compliance with FDA, ISO 13485, GMP, and internal quality requirements.
• Collaborate with Manufacturing, Quality, R&D, and Engineering teams on validation and process improvement projects.
• Support equipment qualifications, process transfers, and new product introductions.
• Develop and maintain technical documentation, including protocols, reports, and SOPs.

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?