Validation Engineer

McKesson; Dallas (TX); Remote; USD 80,000 - 120,000; Full time

Job summary

A healthcare solutions company is seeking an experienced Enterprise Quality Validation Engineer to ensure software systems comply with FDA regulations. Responsibilities include planning and executing validation activities, conducting risk assessments, and collaborating across teams. Candidates should have 3+ years of validation experience and a Bachelor’s degree in science or engineering. This is a remote position, open to candidates within the U.S.

Qualifications

• Minimum 3 years of software validation experience in FDA-regulated environments.
• Hands on, coaching, and collaborative work style required.
• Ability to manage multiple projects simultaneously and communicate effectively.

Responsibilities

• Plan and document validation activities for software systems compliance.
• Draft and execute validation plans and protocols.
• Conduct risk assessments and collaboration with cross-functional teams.

Skills

Software validation

Effectively communicating

Problem-solving

Organizational skills

Interpersonal skills

Education

Bachelor’s degree in science or engineering

Job description

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, including data integrity and 21 CFR Part 11.

Scope of Responsibilities

• 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 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.

Minimum Education & Experience

• 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.

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

Hybrid/Remote/Onsite: REMOTE