Onsite CQV Engineer - Requalification & Validation Lead

Pioneer GMP Consulting; Louisville (KY); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Life insurance

Paid holidays

Flexible PTO

Job summary

Pioneer GMP Consulting seeks a mid- to senior-level CQV Engineer for an onsite engagement at a GMP-regulated manufacturing site in Louisville, CO. Expected start is Q1 2027, duration 3–6 months, with potential extension.

The role requires independent management of assigned systems, hands-on qualification work, and production of inspection-ready documentation. Travel or future assignments may be required.

Qualifications

• 5+ years in CQV, commissioning, qualification, or validation in GMP settings.
• Experience performing periodic reviews and requalification.
• Hands-on with IQ/OQ/PQ protocols and requalification execution.
• Strong technical-writing and documentation practices.
• Ability to work onsite with minimal supervision.

Responsibilities

• Execute periodic reviews and requalification activities for GMP equipment, utilities, facilities, and systems.
• Review existing qualification packages and lifecycle documentation.
• Evaluate changes, deviations, maintenance history, calibration, and prior qualification results.
• Develop and execute requalification protocols.
• Perform hands-on field verification and testing.
• Document discrepancies and closeout documentation.

Skills

CQV experience

Periodic reviews

IQ/OQ/PQ protocols

Documentation writing

GMP knowledge

aCGMP requirements

Education

Bachelor's degree in engineering or life sciences

Tools

Electronic validation systems

Job description

Pioneer GMP Consulting seeks a mid- to senior-level CQV Engineer for an onsite engagement at a GMP-regulated manufacturing site in Louisville, CO. Expected start is Q1 2027, duration 3–6 months, with potential extension.

The role requires independent management of assigned systems, hands-on qualification work, and production of inspection-ready documentation. Travel or future assignments may be required.