CQV Engineer

Job Title
: CQV Engineer

Location
:
West Valley City, Utah

Duration
:
Long Term

We are seeking an experienced CQV Engineer to support Commissioning, Qualification, and Validation (CQV) activities within a pharmaceutical, biotechnology, or medical device manufacturing environment. This role will focus on ensuring that manufacturing equipment, utilities, facilities, and cleanroom systems are commissioned, qualified, and validated in compliance with GMP and regulatory requirements. 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.

• 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.
• Assist with 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.

• 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, clean rooms, 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.