Sr. Associate Validation Engineer

McKesson; Shepherdsville (KY); On-site; USD 66,000 - 109,000; Full time

Job summary

McKesson in Kentucky seeks a Validation Engineer to support the validation program for pharmaceutical storage, transport, and utilities. The role ensures GMP and regulatory compliance through qualification lifecycle activities and data-driven studies.

The engineer authors protocols (DQ/IQ/OQ/PQ), analyzes results, and collaborates with Quality, Operations, and external vendors to maintain validated state across facilities and equipment.

Qualifications

• Bachelor's degree in Engineering or related field required.
• Minimum 3 years of validated systems experience in pharma or related regulated industry.
• Experience authoring qualification protocols and technical reports.
• Familiarity with GDP/GMP and validation lifecycle concepts.
• Knowledge of calibration and environmental monitoring systems.

Responsibilities

• Support Validation Manager in site Validation Program.
• Author and review DQ/IQ/OQ/PQ protocols and reports.
• Coordinate qualification activities for facilities, utilities, equipment, and transport.
• Assist with CAPA, deviations, and change control processes.
• Collaborate with quality, operations, engineering, and vendors.
• Support internal and regulatory audits with validation documentation.

Skills

GMP compliance

Calibration management

Documentation writing

Cross-functional teamwork

Data analysis

Education

Bachelor's degree in Engineering

Tools

Kaye Validators

Data loggers

Calibration systems

MasterControl

Job description

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.

Position Summary:

The Validation Engineer supports the Validation Manager in maintaining facilities, equipment, utilities, and transportation systems used for the storage and distribution of pharmaceutical products in a validated and compliant state. The position is responsible for the planning, execution, documentation, and maintenance of qualification, validation, calibration, and periodic review activities in accordance with current GMP, GDP, and applicable regulatory requirements.

The Validation Engineer authors and executes qualification and validation protocols, analyzes study data, prepares technical reports, and supports change control, deviation investigations, and corrective and preventive action (CAPA) activities related to validated systems. This role works closely with Quality, Operations, Engineering, and external vendors to ensure equipment and facilities remain fit for intended use throughout their lifecycle while supporting continuous improvement of the validation program.

Key Responsibilities

• Support the Validation Manager in the administration and continuous improvement of the site Validation Program.
• Author, execute, review, and maintain validation lifecycle documentation, including DQ, IQ, OQ, PQ, temperature mapping studies, requalification protocols, and summary reports.
• Coordinate and perform qualification activities for facilities, storage environments, utilities, equipment, and transportation systems.
• Support Management of Change (MOC), risk assessments, deviations, CAPAs, and investigations associated with validated systems.
• Conduct data collection, analysis, and technical evaluations to determine acceptance of validation and qualification studies.
• Coordinate/ conduct calibration activities for temperature monitoring devices, data loggers, sensors, and other critical measuring equipment. Review calibration and maintenance records to ensure equipment remains in a qualified and compliant state.
• Assist with the development and maintenance of Validation Master Plans, validation procedures, and related quality system documentation.
• Collaborate with Operations, Facilities, Quality Assurance, and external service providers to support installation and qualification projects.
• Support internal audits, client audits, and regulatory inspections by providing validation documentation and technical expertise.
• Participate in process improvement initiatives designed to enhance compliance, efficiency, and effectiveness of validation and calibration programs.

Education/Training

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline preferred; equivalent combination of education and experience may be considered.

Experience

• Minimum of 3 years of experience in pharmaceutical, medical device, biotechnology, logistics, or other regulated industry validation activities.
• Experience performing equipment, facility, utility, environmental, or transportation qualification studies.
• Experience authoring and executing validation protocols and technical reports.
• Familiarity with pharmaceutical GDP/GMP requirements and validation lifecycle concepts.
• Experience with temperature mapping and thermal validation activities preferred.
• Familiarity with Kaye Validators, data loggers, environmental monitoring systems, and calibration management systems preferred.
• Experience with electronic quality management systems such as MasterControl preferred.

Knowledge and Skills

• Knowledge of FDA regulations, EU GMP guidelines, GAMP principles, and validation lifecycle methodologies.
• Understanding of calibration requirements and applicable standards, including ISO 17025.
• Strong technical writing, data analysis, and problem-solving skills.
• Ability to interpret validation data and prepare scientifically sound conclusions.
• Proficient in Microsoft Office applications for data analysis and reporting.
• Ability to manage multiple projects and priorities while meeting established deadlines.
• Strong interpersonal and communication skills with the ability to collaborate across functional departments.

Travel Requirements:

Ability to travel between product storage facilities within Central and Northern Kentucky and Southern Ohio. Travel to Central Indiana and Texas to assist with validation and calibration activities of transport trailers, as needed. As well as travel to vendor sites, as needed.

Our Base Pay Range for this position

$65,600 - $109,300

We are proud to offer a competitive compensation package 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, click here.

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to [e-mail] or [e-mail]. Resumes or CVs submitted to this email box will not be accepted.

McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:

McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.

McKesson job postings are posted on our career site: careers.mckesson.com.

Join us at McKesson!