Validation Engineer

Title : Validation Engineer

Hub locations : Atlanta, GA; Columbus, OH; Dallas, TX; Richmond, VA

Hybrid / Remote / Onsite : REMOTE

McKesson seeks an Enterprise Quality Validation Engineer for the Enterprise Quality Management function, reporting to the Sr. Director, Enterprise QMS and Quality Engineering. This new function provides validation support for a wide variety of businesses within the McKesson enterprise. The Enterprise Quality Validation Engineer will ensure software systems used in regulated environments comply with FDA requirements and other applicable guidance's, including data integrity and 21 CFR Part 11.

Scope of Responsibilities

Responsibilities for the Enterprise Quality Validation Engineer include, but are not limited to :

• Plans, executes, and documents validation / qualification activities to ensure software systems are fit for their intended use, maintaining data integrity, reliability, and compliance.
• Drafts and executes validation plans, protocols, and reports. Develops and executes software validation protocols (IQ, OQ, PQ) in accordance with risk levels, FDA expectations, and industry standards.
• Creates and maintain validation documentation including plans, scripts, traceability matrices, summary reports, and inventory lists.
• Conducts risk assessments and impact analyses for software systems.
• Collaborates with cross-functional teams (QA, IT, Engineering, Regulatory) to ensure validation efforts are commensurate with risk rankings, aligning with business and compliance needs.
• Reviews and approve validation deliverables from internal teams and third-party vendors.
• Provides guidance on validation / qualification strategies and across McKesson Corporation business units.
• Participates and supports validation training, learning, and workshop sessions.
• Supports Audits and Inspections when needed. This includes preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities.
• Stays current with applicable regulations and industry practices. Provide updates to business areas and update procedures and practices accordingly to align with current regulations and industry standards from BOP, FDA, ISO, EMA and any other applicable domestic and international regulations.

Candidate Profile

Minimum Requirements :

Min Education & Typical Experience or Equivalent Combination

Must be authorized to work in the US. Sponsorship is not available for this position.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please

Our Base Pay Range for this position

$85,100 - $141,800