CSV Engineer

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

South Chicago, United States | Posted on 09/30/2026

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech, it’s about more than just a job—it’s about your career and your future.

Your Role

We are seeking Computer System Validation (CSV) Engineers of varying experience levels to support validation and compliance activities for computerized systems used within regulated life sciences environments. The CSV Engineer will be responsible for ensuring computerized systems are implemented, maintained, and operated in compliance with regulatory expectations, data integrity requirements, and client quality standards.

This position supports a wide range of platforms including laboratory systems, manufacturing systems, automation platforms, quality systems, and enterprise applications.

• Develop and execute Computer System Validation documentation in accordance with regulatory requirements and company procedures.
• Author and review validation plans, user requirements specifications, functional specifications, risk assessments, traceability matrices, test scripts, summary reports, and SOPs.
• Support implementation and validation of computerized systems throughout the system lifecycle.
• Execute and document system testing activities including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT).
• 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 Quality Assurance, 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.
  

Requirements

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline.
• Experience supporting computerized system validation activities within regulated pharmaceutical, biotechnology, medical device, or related industries.
• Understanding of GxP regulations, data integrity requirements, and computerized system compliance principles.
• Experience authoring CSV lifecycle documentation and executing validation testing.
• Familiarity with risk-based validation methodologies and Computer Software Assurance (CSA) concepts.
• Knowledge of electronic records and electronic signature requirements.
• Strong technical writing and documentation skills.
• Excellent analytical, troubleshooting, and problem-solving capabilities.
• Strong communication and stakeholder management skills.
• Ability to manage multiple projects and priorities simultaneously.
• Ability and willingness to travel as required by client projects.
  
• Must be authorized to work in the U.S.
  
• No C2C at this time.
  

Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.