CQV Engineer

Job Title: CQV Engineer
Location: Philadelphia PA
Duration: Long Term

Job Summary

We are seeking a highly motivated CQV (Commissioning Qualification and Validation) Engineer to support commissioning and qualification activities within a GMP-regulated biopharmaceutical manufacturing environment. The CQV Engineer will be responsible for supporting equipment startup system qualification utility validation and process readiness activities to ensure compliance with FDA cGMP and industry standards.

The ideal candidate will work closely with Engineering Manufacturing Quality Assurance Validation and Automation teams to support capital projects facility expansion initiatives and manufacturing operations.

Key Responsibilities

• Support commissioning and qualification activities for manufacturing equipment process systems utilities and cleanroom environments
• Develop and execute commissioning and qualification documentation including FAT SAT IQ OQ and PQ protocols
• Perform equipment qualification for biopharmaceutical manufacturing systems including upstream and downstream process equipment
• Support utility qualification activities involving HVAC purified water systems clean steam compressed gases and environmental monitoring systems
• Coordinate system walkdowns punch list management and turnover documentation activities
• Ensure all CQV activities comply with FDA cGMP GDP and company quality standards
• Collaborate with Automation Engineering Validation and Quality teams during equipment installation startup and qualification phases
• Assist with deviation investigations change control activities and CAPA implementation related to CQV processes
• Review P&IDs engineering drawings SOPs and technical documentation to support qualification activities
• Support technology transfer and facility expansion projects within GMP manufacturing environments
• Participate in internal audits and regulatory inspections by providing CQV documentation and technical support

Required Qualifications

• Bachelors degree in Chemical Engineering Mechanical Engineering Biomedical Engineering Biotechnology or related technical field
• 3 years of CQV validation or qualification experience within biopharmaceutical pharmaceutical or regulated manufacturing industries
• Strong understanding of cGMP FDA regulations GDP and validation lifecycle practices
• Experience executing IQ/OQ/PQ protocols and commissioning activities
• Knowledge of clean utilities HVAC systems aseptic processing and GMP facility operations
• Familiarity with deviation management CAPA and change control systems
• Ability to read and interpret P&IDs engineering drawings and technical specifications
• Strong communication technical writing and problem-solving skills