CQV Engineer

Stark Pharma; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma in Philadelphia, PA is seeking a CQV Engineer to support commissioning, qualification, and validation activities in a GMP biopharmaceutical setting.

The role will involve developing and executing FAT, SAT, IQ/OQ/PQ protocols, reviewing process documentation, and coordinating with engineering, validation, and quality teams to ensure compliant startup and facility readiness for capital projects and manufacturing operations.

Qualifications

• Bachelor's degree in Chemical Engineering or related field.
• 3+ years of CQV/validation experience in regulated manufacturing.
• Experience executing IQ/OQ/PQ protocols and commissioning activities.
• Knowledge of clean utilities and GMP facility operations.

Responsibilities

• Support commissioning and qualification of equipment, systems, utilities, and cleanrooms.
• Develop and execute FAT, SAT, IQ, OQ, and PQ protocols.
• Perform equipment qualification for biopharmaceutical manufacturing systems.
• Support utility qualification: HVAC, water systems, clean steam, gases, environmental monitoring.
• Coordinate walkdowns, punch lists, and turnover documentation.
• Ensure CQV activities comply with FDA, cGMP, GDP, and company standards.
• Collaborate with Automation, Engineering, Validation, and Quality teams.
• Assist with deviation investigations, CAPA, and change control related to CQV.
• Review P&IDs, drawings, SOPs, and technical docs to support qualification.
• Support technology transfer and facility expansion projects.
• Participate in internal audits and regulatory inspections with CQV docs.

Skills

CQV

IQ/OQ/PQ protocols

Validation lifecycle

Biopharma

Education

Bachelor's degree in Chemical Engineering

Job description

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

• Bachelor s 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