CQV Engineer - GMP Validation Expert

Zohorecruit; Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

PSC Biotech is seeking CQV Engineers of varying experience levels to support commissioning, qualification, and validation activities for facilities, utilities, equipment, and manufacturing systems within regulated life sciences environments.

Successful candidates will collaborate with engineering, quality, manufacturing, and project teams to deliver compliant validation solutions while ensuring cGMP compliance and meeting client expectations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline.
• Experience supporting commissioning, qualification, and validation activities within regulated pharmaceutical, biotechnology, medical device, or related industries.
• Working knowledge of cGMP regulations and industry guidance documents.
• Experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Familiarity with risk-based validation methodologies and lifecycle approaches.
• Experience with manufacturing equipment, process systems, clean utilities, facilities, or cleanroom environments.
• Strong technical writing, documentation, and communication skills.
• Ability to troubleshoot technical issues and collaborate across multidisciplinary teams.
• Strong organizational, analytical, and problem-solving abilities.
• Ability and willingness to travel as required by client projects.
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Develop, review, and execute commissioning, qualification, and validation documentation for facilities, utilities, equipment, and manufacturing systems.
• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support commissioning activities including system walkdowns, punch-list resolution, turnover packages, and startup support.
• Perform equipment and utility qualification activities for systems such as HVAC, clean steam, purified water, WFI, compressed gases, CIP/SIP systems, process equipment, and cleanroom environments.
• Support development of validation plans, risk assessments, traceability matrices, and final reports.
• Participate in discrepancy investigations, deviation resolution, CAPA activities, and change control assessments.
• Coordinate with cross-functional stakeholders including Engineering, Manufacturing, Quality Assurance, Automation, and Facilities.
• Review design documentation, specifications, P&IDs, and engineering packages to ensure qualification readiness.
• Ensure compliance with client procedures, GMP requirements, and applicable regulatory standards.
• Support project planning, scheduling, and execution activities to meet client timelines and deliverables.
• Contribute to continuous improvement initiatives and implementation of risk-based validation approaches.
• Travel to client sites as required to support project execution.

Skills

Technical writing

Documentation

Communication skills

Analytical thinking

Problem-solving

Team collaboration

Troubleshooting

Travel willingness

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Bachelor's degree in Biotechnology

Bachelor's degree in Chemistry

Job description

PSC Biotech is seeking CQV Engineers of varying experience levels to support commissioning, qualification, and validation activities for facilities, utilities, equipment, and manufacturing systems within regulated life sciences environments.

Successful candidates will collaborate with engineering, quality, manufacturing, and project teams to deliver compliant validation solutions while ensuring cGMP compliance and meeting client expectations.