Validation Engineering

The Validation Engineer ensures that all pharmaceutical manufacturing equipment, systems, and utilities consistently perform according to design specifications and stringent regulatory standards (FDA, GMP, and GAMP 5). Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Installation Qualification (IQ): Verify and document that equipment, piping, and instrumentation are delivered, installed, and configured exactly according to the manufacturer’s specifications, engineering drawings, and purchase orders.

Operational Qualification (OQ): Test and document the equipment’s operational limits, control systems, alarms, and critical process parameters (CPPs) to ensure it functions as intended throughout its entire operating range.

Performance Qualification (PQ): Demonstrate and document that the integrated system consistently produces a product meeting all predefined quality attributes and specifications under routine, maximum, and worst-case manufacturing conditions.

Regulatory Compliance: Ensure all validation activities comply with Current Good Manufacturing Practices (cGMP), data integrity standards (21 CFR Part 11), and internal Standard Operating Procedures (SOPs).

Partner with Quality Assurance (QA), Engineering, and Production teams to resolve deviations, manage change controls, and ensure systems are safely handed over for routine production.

#