Commissioning, Qualification, and Validation Engineer

Commissioning, Qualification & Validation (CQV) Engineer

Position Summary The Commissioning, Qualification, and Validation (CQV) Engineer is responsible for supporting and executing commissioning, qualification, and validation activities for facilities, utilities, systems, equipment, and processes within a regulated pharmaceutical/biopharmaceutical manufacturing environment.

The CQV Engineer will work cross-functionally with Engineering, Manufacturing, Quality Assurance, Automation, Validation, and external vendors to ensure systems are properly commissioned, qualified, documented, and maintained in a state of compliance with applicable GMP requirements and regulatory expectations.

Key Responsibilities

• Develop and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical manufacturing facilities, utilities, systems, and equipment.
• Develop and execute qualification documentation, including:
• User Requirements Specifications (URS)
• Functional/Design Specifications
• Risk Assessments
• Design Qualification (DQ)
• Factory/Site Acceptance Testing (FAT/SAT)
• Commissioning documentation
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Develop and execute commissioning and qualification protocols and associated reports.
• Support equipment and system startup, commissioning, troubleshooting, and turnover activities.
• Review engineering drawings, specifications, manuals, P&IDs, equipment documentation, and vendor documentation.
• Ensure qualification activities are appropriately linked to critical quality attributes, critical process parameters, and system requirements, where applicable.
• Support qualification of process equipment, facility systems, clean utilities, HVAC, environmental systems, and other GMP systems.
• Coordinate with Engineering and equipment vendors to resolve commissioning and qualification issues.
• Develop and maintain traceability matrices to ensure requirements are adequately addressed through testing and qualification.
• Participate in risk assessments such as FMEA and system impact assessments to establish appropriate qualification strategies.
• Review and approve technical documentation generated during commissioning and qualification activities.
• Identify, document, and investigate discrepancies and deviations encountered during CQV execution.
• Support development and implementation of CAPA and corrective actions associated with CQV activities.
• Support change control, deviation, and validation lifecycle activities.
• Ensure equipment and systems are appropriately calibrated prior to and during qualification activities.
• Review and assess vendor documentation and testing packages for compliance with project and GMP requirements.
• Support preparation for internal and regulatory inspections and provide CQV documentation as required.
• Maintain accurate and complete validation documentation in accordance with applicable SOPs and GMP requirements.
• Work with Quality Assurance to ensure CQV activities are conducted in accordance with approved procedures and regulatory expectations.
• Participate in project meetings and provide technical updates on CQV progress, issues, risks, and deliverables.

Preferred Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related technical discipline.
• 3+ years of experience in commissioning, qualification, validation, or engineering within a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment.
• Demonstrated experience with GMP-regulated facilities, systems, utilities, and/or equipment.
• Hands-on experience developing and executing IQ/OQ/PQ and commissioning protocols.
• Strong understanding of GMP principles and qualification/validation lifecycle requirements.
• Experience with risk assessments, deviations, CAPA, and change control.
• Ability to interpret engineering documentation, equipment specifications, drawings, and technical manuals.
• Strong technical writing and documentation skills.
• Ability to work independently while effectively collaborating with Engineering, Quality, Manufacturing, and external vendors.
• Strong analytical and problem-solving skills.

Technical Skills

• Commissioning & Qualification (C&Q)
• Equipment Qualification
• IQ/OQ/PQ
• Design Qualification
• FAT/SAT
• GMP Validation
• Risk Assessments / FMEA
• Requirements Traceability
• Deviations & CAPA
• GMP Documentation
• Equipment & Utility Qualification

Work Authorization Candidates must be legally authorized to work in the United States. This position is not eligible for employment visa sponsorship.