Description

Manage computer system validation compliance for pharmaceutical process control systems.

Responsibilities

• Write, review, and execute validation documentation including USR, Function Specifications, IQ/OQ/PQ protocols, and Traceability Matrices.
• Validate process control systems for water for injection, water pretreatment, water stills, and high-quality steam generation.
• Assess electronic and paper records to identify Data Integrity gaps using a risk-based approach.
• Record, approve, and resolve all project-related issues and deviations.
• Maintain lifecycle documentation and ensure traceability within the Document Navigator repository.

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 validation experience with Rockwell FactoryTalk and Allen Bradley PLC systems.
• Proficiency with Microsoft SQL Server and Microsoft .NET Framework.
• Proven ability to perform 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 per EU GMP Annex 1 and US FDA Annex 11.
• Familiarity with GAMP5, V-Model, and 21 CFR Part 11.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Graduate