Computer Systems Validation Engineer - Remote

Summary: The Computer Systems Validation Engineer role focuses on ensuring compliance and validation of computer systems within the Pharma/Biopharma industry. The position requires extensive experience in Computer Systems Validation (CSV) and familiarity with various validation tools and methodologies. The role is remote, allowing for flexibility in work arrangements while contributing to critical validation processes. Candidates should possess a strong background in engineering or life sciences.

Key Responsibilities:

• Conduct Computer Systems Validation (CSV) for Pharma/Biopharma systems.
• Validate laboratory systems and interfaces, ensuring compliance with industry standards.
• Author Validation Plans, URS, OQ, PQ, VSR, and Traceability Matrix documentation.
• Utilize validation tools such as HP ALM, Kneat, TrackWise, and Veeva.
• Manage data integrity, interface validation, regression testing, and defect/deviation management.

Key Skills:

• 5+ years of Computer Systems Validation (CSV) experience in Pharma/Biopharma.
• Strong hands-on experience with MODA and/or LabWare LIMS.
• Knowledge of GAMP 5, cGMP, 21 CFR Part 11, GxP, and validation lifecycle.
• Experience with validation tools and documentation.
• Bachelor's degree in Engineering, Life Sciences, or related field.

Salary (Rate): undetermined

City: undetermined

Country: undetermined

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: IT