Job Description

Validation Specialist

Location:

Rochester, NY (On-site)


6 months contract

Salary Range:

$55,925 - $93,209 annually (based on experience and qualifications)

Job Summary

The Validation Specialist will assist the Senior Quality Improver and/or Validation Engineers in carrying out a range of validation and testing tasks necessary to meet domestic and international quality standards within the Global Quality Engineering function. This role will focus particularly on supporting MDR remediation activities at the manufacturing site, including validations, procedural changes, and training support, among other responsibilities.

Essential Functions

Tests systems and implements validation packets. Validates and qualifies equipment for use in manufacturing and quality control testing of products. Assists in drafting validation protocols and reports, as well as developing written maintenance procedures. Identifies and documents potential gaps based on validation tasks performed. Conducts validation exercises for technology and manufacturing systems to support in-line products and processes at manufacturing sites. Performs validation of process equipment installation, operational, and performance qualification studies to assess functionality. Executes operational qualification assessments to ensure critical operating parameters are within qualified parameters. Implements equipment enhancements as directed to support intended qualified operational ranges. Documents deviations and/or investigations related to remediation activities.

Qualifications

Knowledge, Skills and Abilities:

Ability to write technical reports and correspondence. Ability to use statistics and mathematics. Ability to solve practical problems and deal with a variety of concrete and abstract variables in situations where only limited standardization exists. Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred.

Experience:

Minimum of 2-5 years of experience in performing quality validations within a manufacturing environment. Proficient in validation testing and development of statistical process control and monitoring. Previous experience in the medical device industry is a plus.

Education:

Associate Degree or Technical Studies preferably related to the fields of Engineering or Science.
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