C&Q Engineer – Regulated Capital Projects (Contract)

ProQuality Network; United States; Hybrid; USD 110,000 - 170,000; Full time

Job summary

ProQuality Network is seeking an experienced Commissioning & Qualification (C&Q) Engineer to provide advanced validation engineering expertise for a critical capital project. The role uses risk-based CQV principles aligned with ASTM E2500 to ensure systems for cGMP equipment, automation, facilities, and clean utilities are designed, installed, operated, and maintained in a validated state.

The position requires managing multiple projects, developing validation strategies, reviewing

Qualifications

• PhD with 2+ years directly related experience.
• MS with 6+ years directly related experience.
• BS with 8+ years directly related experience.
• Associate degree with 10+ years directly related experience.

Responsibilities

• Review lifecycle documentation (URS, risk, DI assessments).
• Review validation plans, installation, operational and performance verification protocols and reports.
• Support field execution of commissioning and integration testing per approved CQV plans.
• Evaluate protocol discrepancies and deviations, including root cause analysis support.
• Create or revise System Impact and P&ID drawings for impacted circuits.
• Participate in risk assessments and implement appropriate controls.

Skills

Validation engineering

CQV methodologies

Risk assessment

Education

PhD + 2+ years

MS + 6+ years

BS + 8+ years

AS + 10+ years

Job description

ProQuality Network is seeking an experienced Commissioning & Qualification (C&Q) Engineer to provide advanced validation engineering expertise for a critical capital project. The role uses risk-based CQV principles aligned with ASTM E2500 to ensure systems for cGMP equipment, automation, facilities, and clean utilities are designed, installed, operated, and maintained in a validated state.

The position requires managing multiple projects, developing validation strategies, reviewing