Validation Specialist - Sterilization

For Sterilization and Validation support services in the Laboratory area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Natural Science (Biology or Microbiology preferred) and previous exposure of Sterilization Validation activities within the Pharmaceutical or Medical Device Industry. 
• Excellent verbal/written communication skills (English and Spanish) 
• Shift: Administrative & according to business needs
• Ability to work independently and/or collaboratively in order to complete work assignments and tasks. 
• Experience in:
  • Laboratory (micro).
  • Equipment validation protocols development & Ethylene Oxide Sterilization Validation. 
  • Investigations
  • EN ISO 11135, EN ISO 11138 and EN ISO 10993
  • Terminal sterilization validation and/or microbiological or laboratory processes. 

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)

• Write, execute and maintain on a timely basis Validation protocol.
• Ensure timely, thorough, and complete execution of all protocols, meeting FDA requirements.
• Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
• Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
• Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing.
• Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized, and resolution satisfies validation requirements.
• Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents.
• Support the day-to-day process operations.

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?