Role Summary:

The Computer Systems Validation Officer is responsible for ensuring that all computerized systems, including ERP, LIMS, CDS (Chromatography Data Systems), and process control systems, are compliant with regulatory standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). This role ensures that systems are fit for their intended use and maintain data integrity throughout their lifecycle.

Key Responsibilities:

Validation Lifecycle: Author, review, and execute Validation Plans (VP), User Requirement Specifications (URS), Functional Specifications (FS), and Configuration Specifications.

Protocol Execution: Execute and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

Risk Assessment: Perform risk-based validation assessments and gap analyses to ensure GxP compliance.

Data Integrity: Ensure systems meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).

Change Control: Manage and assess changes to validated systems, ensuring re-validation activities are scoped appropriately.

Documentation: Maintain the Validation Master Plan (VMP) and ensure all validation documentation is stored and retained per regulatory requirements.

Vendor Management: Act as the point of contact for software vendors during system upgrades and validation activities.

Audit Support: Provide validation documentation and defend processes during internal and external regulatory audits.

Qualifications & Experience:

Education: Bachelor’s degree in Computer Science, Information Technology, Engineering, or Life Sciences.

Experience: 2–5 years of experience in CSV within a GxP/GMP regulated environment.

Technical Skills: Knowledge of GAMP 5, 21 CFR Part 11, and data integrity guidelines. Experience with ERP (SAP/Oracle) or Lab Systems (Waters/Empower, Agilent) is highly desirable.

Key Competencies:

• Strong technical writing and documentation skills.
• Analytical problem-solving skills.
• Attention to detail and ability to manage multiple projects simultaneously.

• Author, review, and execute Validation Plans (VP), User Requirement Specifications (URS), Functional Specifications (FS), and Configuration Specifications.
• Execute and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Perform risk-based validation assessments and gap analyses to ensure GxP compliance.
• Ensure systems meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
• Manage and assess changes to validated systems, ensuring re-validation activities are scoped appropriately.
• Maintain the Validation Master Plan (VMP) and ensure all validation documentation is stored and retained per regulatory requirements.
• Act as the point of contact for software vendors during system upgrades and validation activities.
• Provide validation documentation and defend processes during internal and external regulatory audits.

• Knowledge of GAMP 5, 21 CFR Part 11, and data integrity guidelines.
• Experience with ERP (SAP/Oracle) or Lab Systems (Waters/Empower, Agilent) is highly desirable.
• Strong technical writing and documentation skills.
• Analytical problem-solving skills.
• Attention to detail and ability to manage multiple projects simultaneously.

• Bachelor’s degree in Computer Science, Information Technology, Engineering, or Life Sciences.