Computer System Validation (CSV) Engineer

Title : Computer System Validation (CSV) Engineer

Locations: Piscataway, NJ  | Chicago, IL 
Work Arrangement: Onsite
Employment Type: Full-Time
Experience: 5+ Years of CSV Experience in a GxP-Regulated Environment

Job Summary

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, manufacturing and engineering equipment, and enterprise applications.

The CSV Engineer will work closely with Quality, IT, Laboratory, and Manufacturing teams to ensure computerized systems remain validated and compliant with GxP, 21 CFR Part 11, EU Annex 11, and applicable EMA requirements.

This is an onsite position reporting to the Sr. Director of IT. The successful candidate will have strong hands-on experience developing and executing CSV deliverables within a regulated life sciences environment.

Key Responsibilities

• Plan, author, review, and execute CSV deliverables, including:
  • Validation Plans
  • User Requirements Specifications (URS)
  • Functional Specifications (FS)
  • Design Specifications (DS)
  • IQ/OQ/PQ protocols
  • Traceability Matrices
  • Validation Summary Reports (VSR)
• Perform CSV activities for:
  • Laboratory instruments such as HPLC, spectrophotometers, and balances
  • Engineering and manufacturing equipment
  • LIMS platforms
  • SAP systems
  • CMMS/calibration systems such as BMRAM
• Partner with System Owners, QA, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state.
• Support change control, periodic reviews, and validation lifecycle activities.
• Conduct computerized system risk assessments and data integrity assessments in alignment with ALCOA+ principles.
• Support audits, regulatory inspections, CAPA investigations, deviations, and compliance activities related to computerized systems.
• Collaborate with senior validation leads and subject matter experts to establish and maintain consistent CSV practices across sites.
• Ensure validation documentation meets applicable regulatory and quality standards.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field, or equivalent laboratory experience within a life sciences environment.
• Minimum 5 years of Computer System Validation (CSV) experience in a GxP-regulated environment.
• Strong working knowledge of:
  • 21 CFR Part 11
  • EU Annex 11
  • EMA guidance
  • GxP compliance requirements
• Hands-on experience authoring and executing IQ/OQ/PQ protocols.

Preferred Qualifications

• Familiarity with GAMP 5 principles.
• Experience with risk-based validation methodologies.
• Exposure to Caliber LIMS.
• Experience with SAP QM, MM, or PP in a GxP environment.
• Experience with BMRAM or comparable CMMS/calibration systems.
• Experience working as a liaison between IT, Quality, Laboratory, and Manufacturing teams.
• Strong understanding of computerized system lifecycle management and data integrity principles.