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Laboratory Validation Specialist

Arroyo, PR
LABORATORY VALIDATION SPECIALIST
 
Description 
Seeking a Laboratory Validation Specialist with experience in the pharmaceutical and medical devices industries.  The candidate must have solid GMP and regulatory experience with expertise in test method validation and laboratory equipment validation. 

Duties & 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 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 
  • Writing protocols & technical reports 
  • Experience in laboratory background for TMV 
  • Experience in writing mechanical test protocols 
  • Experience in Test Method Validation  
  • Experience with Gage R&R
  • Experience in Validation and Verification Activities for Medical devices 
  • Experience in writing reports 
  • Basic understanding and experience on test set up  
Experience
 
5+ years of experience in a related field in pharma or medical device industry
 
Education 
 
Bachelor in Science or Engineering (BSME, BSEE, BSChE, BSIE preferred) 
 
Additional requirements
  • Problem Solving 
  • Sense of urgency 
  • Detail Oriented 
  • Be flexible enough to travel to job sites when need arises. 
  • Willing to work overtime including weekend depending ion 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)
 
Ultimate Solutions Corp is an Equal Opportunity Employer. 
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