Job description
We are seeking a mid-level Commissioning, Qualification & Validation (CQV) (CSV) Specialist to support upcoming FDA GMP qualification activities in the United States.
Work location will depend on client needs, and candidates must have a completed Engineering degree and prior CQV/CSV Validation experience. Recent graduates are not eligible.

TN visa support is available only for qualified candidates with a completed Engineering degree.

Most have GMP / FDA Pharmaceutical Manufacturing experience.

Key Responsibilities:
• Write and execute IQ/OQ/PQ protocols and validation documentation using KNEAT or other software
• Support equipment qualification (autoclaves, washers, CTUs, process equipment)
• Perform cleanroom qualification and temperature mapping studies
• Contribute to deviation investigations, CAPAs, SOP updates,



and GMP documentation
• Collaborate with Engineering, Quality, Manufacturing, and Facilities teams

Requirements:
• Bachelor’s degree in Engineering (required)
• 2–5 years of CQV/Validation/Pharma experience
• Strong hands-on experience in GMP equipment qualification
• Solid understanding of GxP and validation lifecycle principles
• Strong technical writing and verbal skills in English

Contract Details:
• Professional services contract
• Full-time on-site in the U.S.
• 8–12 weeks with possible extension
• Expected start: August 2026
• TN visa support available (NO H1B)

📌 Validation Engineer (Ciudad de México)
🏢 EJ Auto Validation
📍 Ciudad de México