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?