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The Pivot GroupPosted 1 month ago

Validation Engineer - Whitehall Area

$77,000–$117,000 year

On-siteWhitehall, Michigan, United States

Full TimeBachelors DegreeSmall

Job Summary

Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software. Perform risk assessments and generate validation plans, then analyze data to write comprehensive reports summarizing results and conclusions. Investigate and resolve deviations or non-conformances identified during validation activities while collaborating with cross-functional teams to ensure successful outcomes. Maintain all validation documentation in accordance with regulatory requirements and support internal and external audits by providing necessary documentation and expertise. This role requires a Bachelor's degree in Engineering or Life Sciences and 3+ years of experience in a regulated manufacturing environment, with a salary range of $77,000 - $117,000.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or a related technical field
  • 3+ years experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotechnology)
  • Demonstrated understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), ISO 13485, and other relevant industry standards
  • Proven experience in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation)
  • Strong analytical and problem-solving skills with the ability to interpret complex data and make sound technical decisions

Desired Qualifications

  • Additional certifications or training

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