CSV Engineer

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 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.

Benefits

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.

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