Lead Validation Engineer – CSV / DeltaV

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

We are seeking a Lead Validation Engineer – CSV/DeltaV to support a major biologics manufacturing operation in Seattle. The ideal candidate will have extensive experience with DeltaV systems, Computer System Validation (CSV), and GMP-regulated environments.

This role will provide technical leadership for validation activities while working closely with Automation, Engineering, Manufacturing, Quality, and IT teams. The position combines validation strategy and planning with hands‑on protocol development, execution, troubleshooting, and documentation.

Key Responsibilities:

• Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems.
• Develop, review, and execute validation deliverables, including Validation Plans, Risk Assessments, RTMs, IQ/OQ/IOQ protocols, and Validation Summary Reports.
• Support DeltaV implementations, upgrades, expansions, and system modifications.
• Review engineering, functional, design, configuration, and system documentation for compliance.
• Coordinate validation activities across Automation, Engineering, Manufacturing, IT, Quality, and other project teams.
• Lead protocol execution, deviation investigations, issue resolution, and validation documentation closeout.
• Support change controls and validation impact assessments.
• Apply risk-based validation and software assurance principles throughout the system lifecycle.
• Provide technical leadership, guidance, and mentorship to junior validation engineers.

Required Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical discipline.
• 8+ years of Computer System Validation (CSV) experience within GMP-regulated pharmaceutical or biotechnology environments.
• Hands‑on DeltaV validation experience is required.
• Proven experience leading validation projects and coordinating cross‑functional teams.
• Strong experience developing and executing:
• Validation Plans
• Requirements Traceability Matrices (RTMs)
• IQ/OQ/IOQ Protocols
• Validation Summary Reports
• Strong knowledge of GAMP 5, CSV/CSA methodologies, 21 CFR Part 11, Data Integrity, and GMP documentation practices.