Role overview

Qualifications

Bachelor’s Degree in Life Sciences or Engineering
Three years of exposure in EO Sterilization activities within the Medical Devices Industry
Bilingual: Spanish and English
Knowledge of environmental monitoring requirements for the manufacturing of a terminally sterilized device per ISO 14644 series standards

Responsibilities

Develop/modifying, qualifying and implementing Ethylene Oxide sterilization processes with contract sterilizers in accordance with ISO 11135
Manage communications with contract sterilizers and/or laboratories in support of qualification of sterilization processes and associated microbiological/chemical methods
Interpret and evaluate analyses against established specifications and recommend and implement corrective action
Support assessment and/or implementation of environmental monitoring methods for cleanroom manufacturing of a terminally sterilized device

Key facts

Remote from: Anywhere
Full time
Mid-level (2-5 years)
English, Spanish

Hard skills

Steam Sterilization Process Validation Microbiological Culture Chemical Process ISO 10993 Standard Environmental Monitoring

Other skills

Teamwork
Customer Service
Innovation
Communication

About the company

FITS, LLC

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 We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to employment@fitspr.com

Company details

Company size201 - 500

Links

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Job description

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?