CQV Engineer — GMP Validation & Commissioning

biotech; Chicago (IL); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

PSC Biotech is seeking an experienced Validation Engineer to develop, review, and execute commissioning, qualification, and validation documentation for facilities and manufacturing systems in regulated life sciences environments.

You will author IQ/OQ/PQ protocols, support system walkdowns, punch-list resolution, and turnover packages, while coordinating with Engineering, Manufacturing, QA, and Facilities teams. Travel to client sites may be required.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or related technical discipline.
• Experience supporting commissioning, qualification and validation activities in regulated industries.
• Knowledge of cGMP regulations and industry guidance documents.
• Experience authoring IQ/OQ/PQ protocols and validation reports.
• Familiarity with risk-based validation methodologies and lifecycle approaches.

Responsibilities

• Develop, review, and execute commissioning, qualification, and validation documentation for facilities, utilities, equipment, and manufacturing systems.
• Author and execute IQ, OQ, and PQ protocols.
• Support commissioning activities including system walkdowns, punch-list resolution, turnover packages, and startup support.
• Perform equipment and utility qualification for systems such as HVAC, clean utilities, CIP/SIP, and cleanrooms.
• Support development of validation plans, risk assessments, traceability matrices, and final reports.
• Coordinate with cross-functional stakeholders including Engineering, Manufacturing, Quality Assurance, Automation, and Facilities.

Skills

cGMP knowledge

Technical writing

Cross-functional collaboration

Analytical skills

Problem solving

Travel-ready

Education

Bachelor's degree in Engineering or Life Sciences

Job description

PSC Biotech is seeking an experienced Validation Engineer to develop, review, and execute commissioning, qualification, and validation documentation for facilities and manufacturing systems in regulated life sciences environments.

You will author IQ/OQ/PQ protocols, support system walkdowns, punch-list resolution, and turnover packages, while coordinating with Engineering, Manufacturing, QA, and Facilities teams. Travel to client sites may be required.