Validation Specialist - Sterilization
Validation Specialist - Sterilization
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Job Description
For Sterilization and Validation support services in the Laboratory area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors degree in Natural Science (Biology or Microbiology preferred) and previous exposure of SterilizationValidation 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 andEN 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 youre 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 deviationsassociated 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 companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC
Employment Type
Contract
