Sr. Validation Specialist

For Validation services in the Sterile and Filling area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Life Science or Engineering and a minimum of five (5) years of experience in the regulated industry. Excellent written and verbal skills in both English and Spanish.

Technical writing skills and problem-solving skills. Shift: Administrative, and flexible to business needs. Due to validation activities, support must be available for 1st, 2nd, and 3rd shifts. Experience in: Process and Equipment Validation Aseptic Media Fill Studies Smoke Studies Documentation and Regulatory Compliance 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 Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Develop, execute, and document qualification and validation protocols (IQ, OQ, PQ) for equipment, systems, and processes on the sterile product filling line.

Participate in and lead the planning and execution of aseptic media fill simulations, ensuring compliance with cGMP regulations and quality standards to demonstrate control of the aseptic process.

Perform airflow visualization studies (smoke studies) to confirm unidirectional airflow and the integrity of aseptic conditions in the filling areas.

Write technical reports and validation protocols, ensuring all documentation meets FDA regulatory requirements and other applicable pharmaceutical industry standards.

BEING A FITS PIECE COMES WITH PERKS: One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed).

However, that’s not all we have to offer.

Talk with us to find out! 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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