Senior Validation Engineer: GMP Compliance Lead

McKesson; Mason (OH); On-site; USD 66,000 - 109,000; Full time

Job summary

McKesson is seeking a Validation Engineer to support the Validation Manager in maintaining facilities, equipment, utilities, and transport systems in a validated state. You will plan, execute, document, and maintain qualification, validation, calibration, and periodic review activities in line with GMP, GDP, and regulatory requirements.

You will author and execute qualification protocols, analyze data, prepare reports, and support CAPA, deviations, and change control.

Qualifications

• Minimum 3 years in pharmaceutical or regulated validation activities.
• Experience with validation protocols and technical reports.
• Familiar with GDP/GMP, validation lifecycle, and ISO 17025.

Responsibilities

• Support Validation Program administration and improvement.
• Author and maintain DQ/IQ/OQ/PQ documents and reports.
• Coordinate qualification activities for facilities, utilities, and equipment.
• Support MOC, risk assessments, deviations, CAPAs, and investigations.
• Analyze validation data to determine acceptance of studies.

Skills

Regulatory compliance

Data analysis

Technical writing

Cross-functional

MS Office

Education

Bachelor's degree

Tools

Kaye Validators

Data loggers

Environmental monitoring

Calibration management

MasterControl

Job description

McKesson is seeking a Validation Engineer to support the Validation Manager in maintaining facilities, equipment, utilities, and transport systems in a validated state. You will plan, execute, document, and maintain qualification, validation, calibration, and periodic review activities in line with GMP, GDP, and regulatory requirements.

You will author and execute qualification protocols, analyze data, prepare reports, and support CAPA, deviations, and change control.