CSV Engineer (Life Sciences)

Location: South Chicago, United States; travel to client sites is required as needed. U.S. work authorization is required.

Company

Provides validation, compliance, and other essential services to life sciences organizations developing, manufacturing, and distributing healthcare products.

What you will do

• Develop and execute Computer System Validation documentation for regulated computerized systems.
• Author and review validation plans, requirements and functional specifications, risk assessments, traceability matrices, test scripts, summary reports, and SOPs.
• Execute and document IQ, OQ, PQ, and UAT testing throughout the system lifecycle.
• Perform risk-based validation and Computer Software Assurance assessments, including data integrity and electronic records compliance reviews.
• Support change controls, deviation investigations, CAPA activities, periodic reviews, system upgrades, migrations, and enhancements.
• Collaborate with Quality Assurance, IT, Automation, Engineering, Manufacturing, and Laboratory Operations teams, including during audits and client reviews.

Requirements

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline.
• Experience with computerized system validation in pharmaceutical, biotechnology, medical device, or related regulated industries.
• Knowledge of GxP regulations, data integrity, electronic records and signatures, CSV lifecycle documentation, and validation testing.
• Familiarity with risk-based validation methodologies and Computer Software Assurance concepts.
• Strong technical writing, analytical, troubleshooting, problem-solving, communication, and stakeholder management skills.
• Must be authorized to work in the United States; C2C arrangements are not available.

Culture & Benefits

• Work with a multicultural team of life sciences professionals across global operations.
• Access coaching, professional development, and career growth opportunities.
• Compensation and benefits are provided as part of the employment package.
• Participation in wellness, social, recreational, and other employer-sponsored programs.