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CSV Specialist

Juncos, PR

Searching for Validation Specialist with experience in the pharmaceutical industry with CSV.  The candidate must have solid GMP and regulatory experience with expertise in computer system validation (CSV).

  • Must have experience generating and executing computer system validation (CSV) change controls process and validation protocols.
  • 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 and validation activities.
  • Communicate with the staff and management on ways of implementing plans and recommendations.
Skills and Specifications
  • Minimum of 4 years of experience
  • CSV experience is required
  • Strong Technical Writing Skills
  • Project management experience is a plus
  • Problem Solving
  • Sense of urgency
  • Detail Oriented
  • 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)
  • Minimum BA/BS in Computer Science, Electrical Engineering Systems, or equivalent experience and/or field of study
Integrated Technology and Compliance Services is an Equal Opportunity Employer

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