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CQV Engineer

Job in Waukegan, Lake County, Illinois, 60087, USA
Listing for: Shoolin Inc
Full Time position
Listed on 2026-06-07
Job specializations:
  • Engineering
    Pharma Engineer
  • Quality Assurance - QA/QC
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below

Seeking a CQV Engineer to support commissioning, qualification, and validation activities for equipment, utilities, and manufacturing systems in a GMP-regulated facility.

Required Qualifications:
  • 2+ years of CQV/Validation experience
  • Experience executing IQ, OQ, and PQ protocols
  • Knowledge of GMP, FDA, and validation requirements
  • Experience with equipment and utility qualification
  • Strong documentation and technical writing skills
  • Bachelor's degree in Engineering or Life Sciences
Key Responsibilities:
  • Execute commissioning and qualification activities for GMP equipment
  • Develop and review IQ, OQ, and PQ protocols and reports
  • Support deviation investigations and change control activities
  • Coordinate with Engineering, Quality, and Manufacturing teams
  • Ensure validation documentation meets regulatory requirements
  • Maintain compliance with GMP and company procedures
Preferred Qualifications:
  • Experience in pharmaceutical or biotechnology environments
  • Familiarity with cleanroom and utility systems
  • Knowledge of risk assessments and validation lifecycle practices
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