CSV Engineer | GxP Validation for Life Sciences

PSC Biotech; Chicago, Northern (IL, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

PSC Biotech seeks experienced CSV Engineers to support validation and compliance activities for computerized systems in regulated life sciences environments. You will ensure systems are implemented, maintained, and operated in line with regulatory expectations, data integrity and client quality standards.

The role covers laboratory, manufacturing, automation, quality, and enterprise applications, with travel to client sites as required.

Qualifications

• Bachelor's degree in Computer Science or a related discipline.
• Experience supporting computerized system validation activities within regulated life sciences industries.
• Understanding of GxP regulations, data integrity, and computerized system compliance.
• Experience authoring CSV lifecycle documentation and performing validation testing.
• Familiarity with risk-based validation methodologies and CSA concepts.

Responsibilities

• Develop and execute CSV documentation in line with regulatory requirements and company procedures.
• Author and review validation plans, URS, FS, risk assessments, traceability matrices, test scripts and reports.
• Support validation across the system lifecycle and plant platforms.
• Perform IQ/OQ/PQ and UAT testing and document results.
• Conduct risk assessments and ensure data integrity/compliance.
• Collaborate with QA, IT, Automation, Engineering, and Manufacturing teams.
• Participate in system implementations, upgrades, migrations, and enhancements.
• Maintain validated-state through lifecycle management and periodic reviews.
• Support regulatory inspections, audits, and client reviews.

Skills

CSV engineering

GxP knowledge

Data integrity

Regulatory compliance

Documentation

Risk-based validation

CSA concepts

Electronic records

Communication skills

Travel readiness

Work authorization

Education

Bachelor's degree in CS/related field

Job description

PSC Biotech seeks experienced CSV Engineers to support validation and compliance activities for computerized systems in regulated life sciences environments. You will ensure systems are implemented, maintained, and operated in line with regulatory expectations, data integrity and client quality standards.

The role covers laboratory, manufacturing, automation, quality, and enterprise applications, with travel to client sites as required.