CSV Engineer - Life Sciences Validation Specialist

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

Job summary

PSC Biotech is seeking a Computer System Validation (CSV) Engineer to support validation and compliance activities for computerized systems in regulated life sciences settings. The role covers laboratory, manufacturing, automation, quality, and enterprise applications.

You will develop validation documents, perform IQ/OQ/PQ/UAT, conduct risk assessments, and ensure data integrity while collaborating with QA, IT, and operations. Travel to client sites is required.

Qualifications

• Bachelor's degree in a relevant field and strong technical writing abilities.
• Experience supporting computerized system validation activities in regulated life sciences.
• Understanding of GxP regulations and data integrity requirements.
• Experience authoring CSV lifecycle documentation and performing validation testing.
• Familiarity with CSA concepts and electronic records/e-signature principles.

Responsibilities

• Develop and execute CSV validation documentation per regulatory requirements.
• Author and review validation plans, URS, FDS, risk assessments, traceability, test scripts, SOPs.
• Support implementation and validation across the system lifecycle.
• Execute IQ/OQ/PQ/UAT testing and document outcomes.
• Conduct risk assessments using risk-based validation and CSA methodologies.
• Evaluate systems for data integrity and compliance with electronic records.
• Support change control, deviations, CAPA, and periodic reviews.
• Collaborate with QA, IT, Automation, Engineering, Manufacturing, and Lab Ops.
• Participate in software implementation projects, upgrades, migrations, and enhancements.
• Maintain validated state through lifecycle management activities.
• Support regulatory inspections and client audits.
• Travel to client sites as required for validation efforts.

Skills

CSV/CSV validation

Technical writing

Analytical skills

Stakeholder management

Travel-ready

Education

Bachelor's degree in Computer Science or related

Job description

PSC Biotech is seeking a Computer System Validation (CSV) Engineer to support validation and compliance activities for computerized systems in regulated life sciences settings. The role covers laboratory, manufacturing, automation, quality, and enterprise applications.

You will develop validation documents, perform IQ/OQ/PQ/UAT, conduct risk assessments, and ensure data integrity while collaborating with QA, IT, and operations. Travel to client sites is required.