CQV Engineer

Job Overview

The ideal candidate will have strong expertise in validation protocols, equipment qualification, regulatory compliance, and cross-functional collaboration to ensure reliable and compliant manufacturing operations.

Key Responsibilities

• Execute Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, utilities, facilities, and cleanroom systems.
• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support commissioning and qualification of process equipment, HVAC systems, clean utilities, and facility infrastructure.
• Ensure compliance with GMP, FDA, ISPE, ASTM, and company quality standards throughout validation activities.
• Prepare validation documentation, technical reports, summary reports, and protocol deviations.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and Maintenance teams to support project execution.
• Absorb investigations, deviations, CAPA, change control, and risk assessments related to validation activities.
• Participate in equipment startup, factory acceptance testing (FAT), site acceptance testing (SAT), and commissioning activities.
• Maintain validation documentation and ensure all records comply with regulatory and quality system requirements.
• Support continuous improvement initiatives to enhance validation processes, compliance, and operational efficiency.

Required Qualifications

• Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering discipline.
• 3+ years of experience in Commissioning, Qualification, and Validation (CQV), Validation Engineering, or Equipment Qualification within pharmaceutical, biotechnology, or medical device manufacturing environments.
• Hands-on experience developing and executing IQ, OQ, and PQ protocols for manufacturing equipment, utilities, cleanrooms, and facility systems.
• Strong knowledge of GMP, FDA, ISPE, ASTM, validation lifecycle, and regulatory compliance requirements.
• Experience with equipment commissioning, facility qualification, utility validation, and cleanroom validation.
• Familiarity with validation documentation, protocol execution, deviation management, CAPA, change control, and risk assessment processes.
• Experience supporting FAT, SAT, equipment startup, and engineering project activities.
• Strong technical documentation, analytical, troubleshooting, and problem-solving skills.
• Excellent communication and cross-functional collaboration skills with the ability to work effectively in a regulated manufacturing environment.
• Experience working within pharmaceutical, biotechnology, or medical device manufacturing facilities is highly preferred.
• Knowledge of computerized systems validation (CSV), process validation, Lean Manufacturing, or Six Sigma methodologies is an added advantage.