Lab. Equipment Validation Specialist

Location: Dorado, PR, Puerto Rico
Date Posted: 08-24-2018

This position is open for a Validation Specialist with experience in laboratory equipments in the medical device and pharmaceutical.  The candidate must have solid GMP and regulatory experience.

Duties and Responsibilities
  • Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis
  • Implements policies and procedures to validate/qualify laboratory equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards
  • Generate new specifications based on new regulations required by the implementation of a new manufacturing process.
  • Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • Prepares and coordinate qualification activities.
  • Communicate with the staff and management on ways of implementing plans and recommendations.
Skills and Specifications
  • Good problem solvers.
  • Be able to sense needs when they arise.
  • Be organized.
  • Keen eye for detail.
  • Be flexible enough to travel to job sites when need arises.
  • Willing to work overtime including weekend depending on the nature of work available.
  • Able to work with minimum or no supervision
  • Strong interpersonal skills and must work in a team
  • Fully Bilingual (English and Spanish)
Bachelor in Science or Engineering (BSME, BSEE, BSChE, BSIE preferred)

Ultimate Solutions Corp is an Equal Opportunity Employer.
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