Senior Validation Engineer - GMP/Quality Systems

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

Job summary

McKesson in Kentucky seeks a Validation Engineer to support validation lifecycle activities for the storage and distribution of pharmaceutical products in a compliant state.

The role requires authoring and executing DQ/IQ/OQ/PQ protocols, data analysis, and CAPA/change control support, working with Quality, Operations, Engineering, and external vendors to ensure ongoing compliance. Travel to sites is expected.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline preferred.
• Minimum 3 years of experience in pharmaceutical, medical device, biotechnology, logistics, or other regulated industry validation activities.
• Experience authoring and executing validation protocols and technical reports.
• Familiarity with GDP/GMP requirements and validation lifecycle concepts.
• Experience with temperature mapping and thermal validation activities preferred.

Responsibilities

• Author, execute, review, and maintain validation lifecycle documentation (DQ/IQ/OQ/PQ).
• Coordinate qualification activities for facilities, storage environments, utilities, equipment, and transport systems.
• Support Management of Change (MOC), risk assessments, deviations, CAPAs, and investigations.
• Conduct data collection, analysis, and technical evaluations to determine acceptance of studies.
• Coordinate calibration activities for temperature monitoring devices and data loggers.
• Review calibration/maintenance records to ensure qualified state.
• Assist with Validation Master Plans and related quality system documentation.
• Collaborate with Operations, Facilities, Quality Assurance, and vendors to support installations.
• Support internal and client audits and regulatory inspections with validation documentation.

Skills

Validation engineering

GMP/GDP knowledge

Data analysis

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Kaye Validators

Data loggers

Calibration management systems

Job description

McKesson in Kentucky seeks a Validation Engineer to support validation lifecycle activities for the storage and distribution of pharmaceutical products in a compliant state.

The role requires authoring and executing DQ/IQ/OQ/PQ protocols, data analysis, and CAPA/change control support, working with Quality, Operations, Engineering, and external vendors to ensure ongoing compliance. Travel to sites is expected.