Entry-Level CQV Engineer | Pharma Validation & Commissioning

Virtue America; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

Virtue America is seeking an entry-level CQV Engineer to support commissioning, qualification, and validation activities within a regulated Pharmaceutical/Life Sciences environment. You will assist with equipment, utilities, and system qualification to ensure GMP readiness.

The role emphasizes documentation, protocol development, and cross-functional collaboration with QA, Engineering, Facilities, and Manufacturing.

Qualifications

• Basic understanding of CQV principles and GMP context.
• Strong documentation and data-analysis skills are required.
• Excellent attention to detail and organization are essential.
• Ability to communicate clearly in writing and verbally.
• Familiarity with URS, design specs, equipment documentation and functional requirements.
• Knowledge of cGMP, GDP, SOPs, deviations and change control is preferred.
• Proactive collaboration with QA, Engineering, Facilities, Maintenance, Manufacturing, Validation, and QC.

Responsibilities

• Assist with commissioning activities for pharmaceutical facilities, equipment, utilities, and process systems.
• Support IQ, OQ, and PQ execution for equipment, systems, and critical utilities.
• Assist in preparing commissioning and qualification protocols, test scripts, checklists, and supporting documentation.
• Support qualification activities involving HVAC, purified water, clean utilities, compressed gases, process equipment, and environmental systems.
• Review URS, design specifications, equipment documentation, and functional requirements to establish qualification criteria.
• Perform and document equipment inspections, functional tests, alarm checks, interlock verification, and operating-parameter testing.
• Prepare qualification reports, test records, punch-list documentation, traceability matrices, and other CQV deliverables in accordance with GDP requirements.
• Document and assist with investigations of qualification discrepancies, deviations, and test failures.
• Support change-control assessments and determine when requalification or additional testing may be required.
• Coordinate with Engineering and Metrology teams to verify calibration status of instruments used during qualification activities.
• Coordinate with QA, Engineering, Facilities, Maintenance, Manufacturing, Validation, and QC teams during CQV activities.
• Ensure CQV activities follow cGMP, FDA requirements, SOPs, and applicable qualification procedures.

Skills

CQV principles

Technical documentation

Data-analysis skills

Attention to detail

Organizational abilities

Written and verbal communication

Cross-functional collaboration

Regulatory compliance awareness

Education

Bachelor’s or Master’s degree in Chemical Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Virtue America is seeking an entry-level CQV Engineer to support commissioning, qualification, and validation activities within a regulated Pharmaceutical/Life Sciences environment. You will assist with equipment, utilities, and system qualification to ensure GMP readiness.

The role emphasizes documentation, protocol development, and cross-functional collaboration with QA, Engineering, Facilities, and Manufacturing.