Commissioning and Qualification Engineer

Title: CQV Engineer | W2 contract

This position is open exclusively to people who are eligible to work in USA

Location : United States

Job Summary

We are seeking a CQV Engineer to support commissioning, qualification, and validation activities in a GMP-regulated pharmaceutical/biopharma environment. This role will focus on executing IQ/OQ/PQ protocols for equipment, utilities, and facility systems while ensuring compliance with regulatory standards.

Key Responsibilities

Execute commissioning and qualification (C&Q) activities Author and execute IQ/OQ/PQ protocols and reports Support equipment, utilities, and facility validation Document and investigate deviations during qualification Ensure compliance with GMP, FDA, and industry regulations Maintain audit-ready validation documentation Collaborate with Engineering, Quality, and Manufacturing teams

Required Qualifications

Bachelor’s degree in Engineering or related field 3–8+ years of CQV/validation experience Hands-on experience with IQ/OQ/PQ execution Experience in pharma/biopharma or regulated manufacturing Strong understanding of GMP and validation practices

Preferred Qualifications

Experience with utilities (HVAC, WFI, clean steam, compressed air) Exposure to DeltaV, PLC, or automation systems Knowledge of FMEA / risk-based validation