CQV Engineer

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

We are seeking a motivated and detail-oriented Entry-Level CQV (Commissioning, Qualification & Validation) Engineer to support facility, utility, equipment, and system qualification activities within a regulated Pharmaceutical/Life Sciences environment. This role will assist with commissioning activities, qualification testing, validation documentation, and compliance requirements to ensure systems are properly installed, tested, and ready for GMP operations.

Key Responsibilities:

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

Required Skills:

• Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Pharmaceutical Engineering, Biotechnology, Life Sciences, or a related field.
• Basic understanding of Commissioning, Qualification, and Validation (CQV) principles.
• Familiarity with IQ, OQ, PQ, URS, FAT, SAT, and equipment qualification concepts.
• Basic understanding of pharmaceutical facilities, manufacturing equipment, and critical utility systems.
• Knowledge of cGMP, GDP, SOPs, deviations, CAPA, and change control is preferred.
• Strong technical documentation and data-analysis skills.
• Excellent attention to detail and organizational abilities.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability to collaborate effectively with Engineering, Quality, Manufacturing, and Validation teams in a regulated Pharma/Life Sciences environment.