What are the responsibilities and job description for the Computer System Validation Engineer position at QvalFocus Inc.?
Job Description: CSV Engineer
Location: Kankakee, IL
Work Type: On-Site (Monday–Friday)
Duration: ASAP – June 31, 2026 (extension possible) (W2 Only)
We are hiring a Computer System Validation (CSV) Engineer to support validation and documentation activities for manufacturing and automation systems at our client’s facility. The role involves ensuring all computerized systems used in production meet GMP, FDA, and data integrity requirements.
- Plan and perform validation for new and existing manufacturing systems.
- Prepare validation documents such as URS, test protocols (IQ/OQ/PQ), reports, and risk assessments.
- Execute IQ/OQ/PQ testing and record evidence.
- Ensure systems meet FDA 21 CFR Part 11 and data integrity requirements.
- Support change controls for any software or hardware updates.
- Perform periodic reviews of validated systems to ensure compliance and proper functionality.
- Work with Operations, Engineering, QA, Automation, and IT teams to resolve issues and maintain system compliance.
- Support audits, inspections, deviations, and CAPA related to computerized systems.
- PLC/SCADA systems
- MES systems
- DCS systems
- Utility systems like WFI, Purified Water, CIP/SIP
- Environmental monitoring systems
- Data historians (e.g., OSI-PI)
- Bachelor’s degree in Engineering, IT, Automation, Biotechnology, or related field.
- 5 years of CSV experience in a GMP environment.
- Experience validating automation systems (PLC/SCADA/DCS).
- Knowledge of data integrity and GAMP 5 guidelines.
- Strong documentation and communication skills.