Sr. Associate Validation Engineer

McKesson•Mason, KY

7d•Hybrid

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

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.