Senior Validation Engineer — Pharma Quality & Compliance Impact

McKesson; Shepherdsville (KY); On-site; USD 66,000 - 109,000; Full time

Job summary

McKesson in Kentucky seeks a Validation Engineer to support the validation program for pharmaceutical storage, transport, and utilities. The role ensures GMP and regulatory compliance through qualification lifecycle activities and data-driven studies.

The engineer authors protocols (DQ/IQ/OQ/PQ), analyzes results, and collaborates with Quality, Operations, and external vendors to maintain validated state across facilities and equipment.

Qualifications

• Bachelor's degree in Engineering or related field required.
• Minimum 3 years of validated systems experience in pharma or related regulated industry.
• Experience authoring qualification protocols and technical reports.
• Familiarity with GDP/GMP and validation lifecycle concepts.
• Knowledge of calibration and environmental monitoring systems.

Responsibilities

• Support Validation Manager in site Validation Program.
• Author and review DQ/IQ/OQ/PQ protocols and reports.
• Coordinate qualification activities for facilities, utilities, equipment, and transport.
• Assist with CAPA, deviations, and change control processes.
• Collaborate with quality, operations, engineering, and vendors.
• Support internal and regulatory audits with validation documentation.

Skills

GMP compliance

Calibration management

Documentation writing

Cross-functional teamwork

Data analysis

Education

Bachelor's degree in Engineering

Tools

Kaye Validators

Data loggers

Calibration systems

MasterControl

Job description

McKesson in Kentucky seeks a Validation Engineer to support the validation program for pharmaceutical storage, transport, and utilities. The role ensures GMP and regulatory compliance through qualification lifecycle activities and data-driven studies.

The engineer authors protocols (DQ/IQ/OQ/PQ), analyzes results, and collaborates with Quality, Operations, and external vendors to maintain validated state across facilities and equipment.