CSV Engineer - Life Sciences Validation & Compliance

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

Job summary

PSC Biotech is seeking Computer System Validation Engineers to support validation and compliance activities for computerized systems used within regulated life sciences environments. The CSV Engineer will ensure computerized systems are implemented, maintained, and operated in compliance with regulatory expectations, data integrity requirements, and client quality standards.

This role spans laboratory, manufacturing, automation, quality, and enterprise applications, including IQ/OQ/PQ/UAT

Qualifications

• Experience validating computerized systems in regulated life sciences industries.
• Familiarity with CSA concepts and electronic records/e-signatures.
• Ability to author CSV lifecycle documentation and tests.
• Willingness to travel to client sites.
• Authorized to work in the U.S. and no C2C.

Responsibilities

• Develop and execute CSV documentation per regulatory requirements and company procedures.
• Author and review validation plans, user requirements specifications, functional specs, risk assessments, traceability matrices, test scripts, summary reports, and SOPs.
• Support implementation and validation of computerized systems throughout the system lifecycle.
• Execute and document IQ, OQ, PQ, and UAT testing.
• Conduct risk assessments utilizing risk-based validation and CSA methodologies.
• Evaluate computerized systems for compliance with data integrity and electronic records requirements.
• Support change control, deviation investigations, CAPA activities, and periodic system reviews.
• Collaborate with QA, IT, Automation, Engineering, Manufacturing, and Laboratory Operations teams.
• Participate in software implementation projects, upgrades, migrations, and system enhancements.
• Ensure validated-state maintenance through lifecycle management activities.
• Support regulatory inspections, audits, and client reviews.
• Maintain project documentation and ensure compliance with client and industry standards.
• Travel to client sites as required to support system implementation and validation efforts.

Skills

CSV validation

IQ/OQ/PQ/UAT

Regulatory compliance

Data integrity

Documentation

Analytical skills

Stakeholder communication

Multi-project management

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, Biotechnology

Job description

PSC Biotech is seeking Computer System Validation Engineers to support validation and compliance activities for computerized systems used within regulated life sciences environments. The CSV Engineer will ensure computerized systems are implemented, maintained, and operated in compliance with regulatory expectations, data integrity requirements, and client quality standards.

This role spans laboratory, manufacturing, automation, quality, and enterprise applications, including IQ/OQ/PQ/UAT