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Integrated Resources, Inc ( IRI ) Logo

Process Validation Engineer

Actively Reviewing the Applications

Integrated Resources, Inc ( IRI )

India Contract On-site
Posted 1 day ago Apply by June 7, 2026

Job Description

Title: Process Validation Engineer/Quality Assurance Engineer


Location: Hebron, KY


Duration: 12+ months W2 contract with high possibility of extension based on performance and business needs



Job Description:

  • The Quality Assurance Engineer is part of the Process Validation Group, specializing in all types of validation deliverables.
  • The Quality Assurance Engineer is a key member of the PV team, reporting to the Senior Manager, Process Validation.
  • You will collaborate with senior QA staff, taking responsibility for Process Validation Reagents within Reagent Manufacturing.


Key Responsibilities:

  • Write and conduct IOQ and spreadsheet validations.
  • Complete PQ, TMV, AQ validations.
  • Develop, maintain, monitor, and audit the quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.


Essential Requirements:

  • Bachelor’s degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) and 5+ years of experience in the medical device industry.
  • Familiarity with CFR 21 Part 820 and ISO 13485.
  • Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems.


Preferred Qualifications

It would be a plus if you also possess previous experience in:

  • Knowledge of PQ, TMV, AQ, NPSV validations.
  • Exposure to GAMP5 or similar regulations.
  • ASQ Certified Quality Engineer (CQE) certification
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