Lead CSV Engineer - DeltaV Validation & GMP Expert

United Pharma; California (MO); On-site; USD 140,000 - 170,000; Full time

Job summary

United Pharma in Seattle seeks a Lead Validation Engineer – CSV/DeltaV to lead validation activities for DeltaV-based manufacturing systems in a GMP setting. You will shape validation strategy, develop protocols, and mentor junior engineers across Automation, Engineering, Manufacturing, Quality, and IT teams.

The role combines hands-on protocol development, execution, troubleshooting, and thorough documentation, including IQ/OQ/IOQ, RTMs, and Validation Summary Reports, with risk-based

Qualifications

• 8+ years of CSV experience in GMP settings.
• Hands‑on DeltaV validation experience.
• Experience leading cross‑functional validation projects.

Responsibilities

• Lead CSV activities for DeltaV-based systems.
• Develop and review validation deliverables (IQ/OQ/IOQ, RTMs, validation plans).
• Coordinate validation across Automation, Engineering, Manufacturing, IT, and Quality.
• Provide mentorship to junior validation engineers.
• Ensure compliance with GMP and 21 CFR Part 11.

Skills

DeltaV

CSV

GMP

Cross-functional leadership

Risk-based validation

21 CFR Part 11

Education

Bachelor's degree

Job description

United Pharma in Seattle seeks a Lead Validation Engineer – CSV/DeltaV to lead validation activities for DeltaV-based manufacturing systems in a GMP setting. You will shape validation strategy, develop protocols, and mentor junior engineers across Automation, Engineering, Manufacturing, Quality, and IT teams.

The role combines hands-on protocol development, execution, troubleshooting, and thorough documentation, including IQ/OQ/IOQ, RTMs, and Validation Summary Reports, with risk-based