Description

Manage computer system validation compliance for pharmaceutical process control systems in Rocky Mount, NC.

Responsibilities

• Resolve fundamental Computer System Validation compliance issues on assigned projects.
• Write, review, and execute validation documentation including USR, Function Specifications, IQ/OQ/Protocol, Traceability Matrices, and Validation Reports.
• Validate computerized systems using GAMP5 and V-Model methodologies.
• Assess electronic and paper records to identify Data Integrity gaps using a risk-based approach.
• Record, approve, and dispense all project-related issues and deviations while maintaining document traceability.

Required Skills

• 8+ years of experience in the pharmaceutical field with a focus on Computer System Validation.
• Experience validating PLC, HMI, SCADA, and historian systems.
• Hands-on experience with Rockwell FactoryTalk, Microsoft SQL Server, Microsoft .NET Framework, and Allen Bradley PLC systems.
• Proficiency in input and output testing.
• Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment.
• Deep knowledge of Good Documentation Practices (GDP).
• Knowledge of Data Integrity Assurance according to EU GMP Annex 1 and US FDA Annex 11.
• Familiarity with GAMP and 21 CFR Part 11 regulations.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Graduate