Job Description

For Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering and previous exposure to validation quality activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
• Protocol development, execution, investigations, and technical documentation.
• Minitab, JMP, or similar statistical analysis tools.
• EO/EtO sterilization processes and validation activities (preferred)
• Working with external suppliers and supplier qualification projects (preferred)
• GMP & GDP

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)

• Development and execution support of validation protocols and reports.
• Change control support (CRs, TRs, VPs, protocol execution, evidence compilation, and closure activities).
• Qualification and operational readiness activities across systems, processes, and infrastructure.
• Cross-functional coordination with Engineering, Quality, Operations, Planning, Supply Chain, and external suppliers.
• Support for SOP updates, training, UAT activities, implementation readiness, and post-implementation support.
• Technical support for supplier qualification and validation activities.

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?