Senior Validation Engineer - GMP Compliance & QA

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

Job summary

McKesson is seeking a Validation Engineer to support the site Validation Program, authoring and executing qualification protocols for facilities, storage environments, utilities, and equipment. You will coordinate calibration activities and collaborate with Quality, Operations, and external vendors to ensure ongoing compliance across the lifecycle.

The role requires a Bachelor’s degree in a technical field and 3+ years of validated-system experience, with strong data analysis and technical

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline preferred.
• 3+ years in pharma/medical device validation activities.
• Experience with qualification studies and validation protocols.
• Familiarity with GMP, GDP, and regulatory requirements.
• Experience with calibration and environmental monitoring.

Responsibilities

• Support Validation Manager in site Validation Program improvements.
• Author, execute, review, and maintain validation lifecycle docs.
• Coordinate qualification activities for facilities, storage, utilities, equipment.
• Support MOC, risk assessments, deviations, CAPAs and investigations.
• Perform data collection, analysis, and technical evaluations for validation acceptance.
• Coordinate calibration activities for sensors and data loggers.

Skills

Technical writing

Data analysis

Problem solving

Interpersonal communication

Project coordination

Education

Bachelor's degree in Engineering/ Life Sciences/ Quality

Tools

Kaye Validators

Data loggers

Calibration management systems

MasterControl

Job description

McKesson is seeking a Validation Engineer to support the site Validation Program, authoring and executing qualification protocols for facilities, storage environments, utilities, and equipment. You will coordinate calibration activities and collaborate with Quality, Operations, and external vendors to ensure ongoing compliance across the lifecycle.

The role requires a Bachelor’s degree in a technical field and 3+ years of validated-system experience, with strong data analysis and technical