Senior Validation Engineer — GMP/QA Compliance

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

Job summary

McKesson Corporation in the United States is seeking a Validation Engineer to support the Validation Manager in maintaining validated facilities, equipment, and transport systems used for storage and distribution of pharmaceutical products. You will plan, document, and execute qualification activities in line with GMP, GDP, and regulatory requirements.

You will author and review validation protocols, support change control and CAPAs, and collaborate with Quality, Operations, Engineering, and

Qualifications

• 3+ years of validated lifecycle experience in pharma or medical devices.
• Experience with qualification studies for equipment, facilities, or utilities.
• Experience authoring validation protocols and technical reports.

Responsibilities

• Assist Validation Manager in maintaining the site Validation Program.
• Author and maintain validation lifecycle documentation (DQ/IQ/OQ/PQ).
• Coordinate qualification activities for facilities, storage, utilities, equipment, transport.
• Support MOC, risk assessments, deviations, CAPAs and investigations.
• Conduct data collection and analysis to determine validation acceptance.
• Collaborate with Operations, Facilities, QA and vendors for projects.
• Support audits by providing validation documentation.

Skills

Data analysis

Technical writing

Cross-functional collaboration

Problem-solving

Microsoft Office

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Tools

Kaye Validators

Data loggers

Environmental monitoring

Calibration management

MasterControl

Job description

McKesson Corporation in the United States is seeking a Validation Engineer to support the Validation Manager in maintaining validated facilities, equipment, and transport systems used for storage and distribution of pharmaceutical products. You will plan, document, and execute qualification activities in line with GMP, GDP, and regulatory requirements.

You will author and review validation protocols, support change control and CAPAs, and collaborate with Quality, Operations, Engineering, and