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Equipment Validation Engineer

1 month ago

Jersey City, New Jersey, United States RevereIT LLC Full time

Job Title: Equipment Validation Engineer

Location: Jersey city, NJ

Job Description:

We are seeking an experienced Equipment Validation Engineer for a long-term project with a leading pharmaceutical/biotech client. The ideal candidate will have a strong background in equipment validation within regulated environments and be capable of independently developing and executing complete validation lifecycle documentation.

Responsibilities:

  • Develop comprehensive validation plans, including IQ, OQ, PQ, and CQ protocols
  • Execute validation protocols and document test results in accordance with cGMP and regulatory guidelines
  • Collaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure validation activities align with project timelines
  • Perform risk assessments and ensure all equipment meets user and process requirements
  • Troubleshoot issues and deviations during qualification activities and support CAPA processes as needed
  • Maintain all validation documentation in compliance with internal SOPs and industry regulations (FDA, EU GMP)

Requirements:

  • Minimum 5+ years of hands-on Equipment Validation experience in pharma/biotech/medical device industry
  • Proven experience in writing and executing full validation lifecycle documentation (IQ/OQ/PQ/CQ)
  • Strong understanding of FDA regulations, GMP, and industry standards
  • Excellent communication, technical writing, and documentation skills
  • Ability to work independently with minimal supervision