Validation Engineer

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

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

• Hands on, coaching, and collaborative work style.
• Demonstrated ability to communicate across a matrix structure and facilitate in a cross-functional environment.
• Highly organized and proficient in working in matrixed organization to support business and program needs.
• Strong interpersonal, verbal, and written communication skills, with the ability to manage multiple different projects simultaneously.

Minimum Requirements:

• Minimum 3 years of software validation experience in pharmaceuticals, medical devices, or other FDA-regulated industries.

• Minimum Bachelor's degree in science or engineering required for this position.
• Able to operate effectively in a highly matrixed environment. Problem-solver with the ability to translate qualitative and quantitative information into actionable recommendations.
• Able to inspire the trust, confidence, and respect of peers and leaders.

Min Education & Typical Experience or Equivalent Combination

• Degree or equivalent and typically requires 4+ years of relevant experience.

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, pleaseclick here.

Our Base Pay Range for this position

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

Join us at McKesson!