Senior CQV Engineer

i-Pharm GxP; Illinois; On-site; USD 130,000 - 170,000; Full time

Job summary

i-Pharm GxP seeks a senior CQV engineer for a 12-month contract in Illinois, with international travel to Europe for FATs. You will lead early qualification, review vendor documentation (URS, FDS, drawings, FAT/SAT protocols), and ensure equipment is ready before shipment.

The role requires 8+ years CQV experience, proven FATs execution, strong GMP knowledge, and comfort traveling internationally. You will work with vendors and the project team to resolve deviations and document results.

Qualifications

• 8+ years of CQV experience in pharmaceutical or biopharmaceutical manufacturing.
• Proven track record executing FATs on process equipment.
• Strong documentation review background across the validation lifecycle.
• Comfortable with regular international travel, including to Europe.
• Solid understanding of cGMP and qualification standards (e.g. ASTM E2500, GAMP 5).

Responsibilities

• Review vendor and project documentation (URS, FDS, drawings, FAT/SAT protocols, turnover packages) for technical accuracy and GMP compliance.
• Plan, execute and document FATs at vendor facilities, including witnessing tests and recording results.
• Identify, log and track deviations and punch items through to resolution with vendors and the project team.
• Confirm equipment readiness for shipment and support handover into SAT and site C&Q.
• Act as the client's technical point of contact with vendors during FAT.
• Work in line with GMP, GDP and HSE standards.

Skills

CQV experience

FATs

Documentation review

International travel

GMP knowledge

Job description

Contract: 12-Month Contract (with anticipated extensions)

Location: Illinois – with international travel to vendor sites in Europe for FATs

Start Date: Late November 2026

Overview

We are supporting a leading biopharma client on a major capital project and are building a small core team of four experienced engineers to lead the early qualification phase. This team will own documentation review and Factory Acceptance Testing (FATs) at vendor sites, making sure equipment is right before it ships. This is a hands‑on, senior role for people who have done FATs before and are comfortable travelling, including extended trips to vendor facilities in Europe.

Key Responsibilities

• Review vendor and project documentation (URS, FDS, drawings, FAT/SAT protocols, turnover packages) for technical accuracy and GMP compliance
• Plan, execute and document FATs at vendor facilities, including witnessing tests and recording results
• Identify, log and track deviations and punch items through to resolution with vendors and the project team
• Confirm equipment readiness for shipment and support handover into SAT and site C&Q
• Act as the client's technical point of contact with vendors during FAT
• Work in line with GMP, GDP and HSE standards

Required Experience

• 8+ years of CQV experience in pharmaceutical or biopharmaceutical manufacturing
• Proven track record executing FATs on process equipment
• Strong documentation review background across the validation lifecycle
• Comfortable with regular international travel, including to vendor sites across Europe
• Solid understanding of cGMP and qualification standards (e.g. ASTM E2500, GAMP 5)

Preferred Experience

• Previous experience travelling to Europe to carry out FATs with European equipment vendors
• Biologics, plasma or sterile manufacturing experience
• Experience on large-scale or greenfield capital projects
• Previous work in a small, senior core team setting up a project's qualification approach