Commissioning And Qualification Lead Consultant - 2454352

ProQuality Network; United States; Hybrid; USD 120,000 - 180,000; Full time

Job summary

ProQuality Network seeks a Senior CSV Lead Consultant to drive validation activities in drug product operations within a regulated manufacturing environment. The role focuses on CSV, C&Q, CQV, and data integrity across the project lifecycle, with SME support across design, engineering, commissioning, and validation.

The candidate will develop and execute validation plans, review URS and risk assessments, and ensure compliance with cGMP standards.

Qualifications

• LeadCSV, C&Q, CQV, qualification, and validation activities across the project lifecycle.
• Provide SME support across design, engineering, commissioning, qualification, and validation activities.
• Develop, review, and execute validation plans, protocols, reports, URS, risk assessments, and qualification documentation.

Responsibilities

• Lead CSV, C&Q, CQV, qualification, and validation activities throughout the project lifecycle.
• Provide SME support across design, engineering, commissioning, qualification, and validation activities.
• Develop, review, and execute validation plans, protocols, reports, URS, risk assessments, and qualification documentation.
• Support validation of computerized systems, equipment, facilities, utilities, HVAC, and environmental systems.
• Review and support FAT/SAT, commissioning packages, and qualification deliverables.
• Apply cGMP, data integrity, and validation compliance requirements.
• Manage validation-related deviations, CAPA, troubleshooting, root cause analysis, and issue resolution.
• Coordinate execution with Engineering, Quality, Manufacturing, vendors, and contractors.
• Support audits, inspections, regulatory submissions, and validation program readiness.
• CSV / C&Q / CQV / Validation Lifecycle
• Risk-Based Validation / Risk Assessments / Root Cause Analysis / CAPA
• cGMP / Data Integrity / Compliance
• Technical Writing / Document Management / KPI Tracking
• SME Support / Cross-Functional Coordination / Project Execution

Skills

CSV Lead

C&Q CQV

Validation Lifecycle

GxP

Data Integrity

Regulatory Compliance

Technical Writing

CAPA

Root Cause Analysis

Cross-Functional Coordination

Job description

Commissioning And Qualification Lead Consultant - 2454352

Position Overview

Our client is seeking a Senior Computer System Validation (CSV) Specialist with strong C&Q, CQV, Engineering, Validation, and compliance SME expertise to support Drug Product operations in a regulated manufacturing environment.

Key Responsibilities

• Lead CSV, C&Q, CQV, qualification, and validation activities throughout the project lifecycle.
• Provide SME support across design, engineering, commissioning, qualification, and validation activities.
• Develop, review, and execute validation plans, protocols, reports, URS, risk assessments, and qualification documentation.
• Support validation of computerized systems, equipment, facilities, utilities, HVAC, and environmental systems.
• Review and support FAT/SAT, commissioning packages, and qualification deliverables.
• Apply cGMP, data integrity, and validation compliance requirements.
• Manage validation-related deviations, CAPA, troubleshooting, root cause analysis, and issue resolution.
• Coordinate execution with Engineering, Quality, Manufacturing, vendors, and contractors.
• Support audits, inspections, regulatory submissions, and validation program readiness.
• CSV / C&Q / CQV / Validation Lifecycle
• Risk-Based Validation / Risk Assessments / Root Cause Analysis / CAPA
• cGMP / Data Integrity / Compliance
• Technical Writing / Document Management / KPI Tracking
• SME Support / Cross-Functional Coordination / Project Execution