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?
Flexible & Integrated Technical Services, LLC (FITS) is a service provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services. The company specializes in providing top-quality technical talent to Pharmaceutical, Medical Device, and Manufacturing industry clients, with a particular focus on sterilization services and validation. FITS operates across the Caribbean region and the United States, emphasizing a family-oriented culture centered on employee well-being. The company distinguishes itself through its commitment to treating employees as the most important part of the organization while delivering specialized technical expertise in areas such as Ethylene Oxide sterilization processes, environmental monitoring, and regulatory compliance.
