Sr. Associate Validation Engineer
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Job Summary
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 tomorrows 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
Bachelors 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.
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 McKessons 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
$65600 - $109300McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKessons (or affiliated entities like CoverMyMeds or RxCrossroads) name in fraudulent emails job postings or social media 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: .
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 McKessons 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 (United States) or (Canada) . Resumes or CVs submitted to this email box will not be accepted.
Join us at McKesson!
Required Experience:
Senior IC
About Company
McKesson is the leading healthcare company for wholesale medical supplies & equipment, pharmaceutical distribution, and healthcare technology solutions. McKesson is the central nervous system of health care. At any given moment, in any given minute, we simultaneously execute thousands ... View more
