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Validation Specialist (north region)

Puerto Rico, Puerto Rico

DESCRIPTION
The Validation Specialist will provide support to the engineering and quality department in the validation of equipment or process for the manufacturing and packaging areas.
The candidate must have validation experience in regulated environment industries such as pharmaceutical, bio-pharmaceutical or medical devices companies.
 
TASKS
  • Generate, execute, review, and/or complete qualification/validation documentation.
  • Complete Master Validation Plan, IQ/OQ/PQ, Process Characterization, Software Validation, Test Method Validation, and associated data for conformance to regulations.
 
KNOWLEDGE
Strong knowledge in FDA Regulation, GMP’s, SOPs, specifications, equipment lifecycle and statistical analysis.

EDUCATION
Bachelor Degree in Engineering or Science and 5 years or more of experience

REQUIREMENTS
  • A solid understanding of validation guidelines.
  • GMP and regulatory experience.
  • Experience in writing and executing validation documentation.
  • Experience with Technical Writing preferred.
  • Statistical knowledge experience is preferred.
  • Project Management knowledge preferred.
  • Availability to work in different shifts. 
  • Fully Bilingual (English/Spanish)

Ultimate Solutions Corp is an equal opportunity employer.


 

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