Project Validation Specialist - Sterilization

Añasco, PR, Puerto Rico
Contracted
Medical Device
Experienced

For Project Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering or Science and at least seven (7) years of exposure to sterilization activities within the Pharmaceutical or Medical Devices industry. ,
  • Bilingual (Spanish and English)
  • Shift: Administrative & according to business needs 
  • Experience in:
    • Sterilization Cycle Changes 
    • Ethylene Oxide Sterilization validation and dose audit management
    • Project Management
    • GMP & GDP regulations

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)

  • Ensure efficient and timely completion of project deliverables related to sterilization area including, but not limited to new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements, among others.
  • Interpreting microbiological testing data, monitoring, and maintaining the sterility assurance used in medical device manufacturing. 
  • Interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects.
  • Conduct microbial test method validations and manage projects independently.
  • Create and change used in operations for microbiological monitoring of the environment and products.

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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