Principal Sterilization

For Sterilization services in the Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Life Sciences or Engineering and three (3) years of exposure in EO Sterilization activities within the Medical Devices Industry.
• Type: Remote
• Bilingual: Spanish and English
• Soft Skills: Excellent teamwork skill
• Experience in:
  • Ethylene Oxide Sterilization Process Validations per ISO 11135
  • Knowledge in supporting microbiological and chemical methods to support EO sterilization per applicable standards
  • Knowledge of environmental monitoring requirements for the manufacturing of a terminally sterilized device per ISO 14644 series standards.

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 of 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)

• Responsible for developing/modifying, qualifying and implementing Ethylene Oxide sterilization processes with contract sterilizers in accordance with ISO 11135 and applicable international standards.
• Managing communications with contract sterilizers and/or laboratories in support of qualification of sterilization processes and associated microbiological/chemical methods (i.e. ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, ISO 10993-7).
• Interprets and evaluates the analyses against established specifications and recommends and implements corrective action where necessary.
• Support assessment and/or implementation of environmental monitoring methods for cleanroom manufacturing of a terminally sterilized device in accordance with ISO 14644 series standards, EN 17141 and applicable standards.
• May also be involved in establishing requirements for the transfer of methodology from R&D.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on 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?

Originally posted on Himalayas