Senior Associate Validation Engineer

• Support the Validation Manager in administering and continuously improving 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, 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 and 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 developing and maintaining Validation Master Plans, validation procedures, and related quality system documentation
• Collaborate with Operations, Facilities, Quality Assurance, and external service providers on installation and qualification projects
• Support internal audits, client audits, and regulatory inspections by providing validation documentation and technical expertise
• Participate in process improvement initiatives to enhance compliance, efficiency, and effectiveness of validation and calibration programs

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline preferred; equivalent combination of education and experience may be considered
• 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 Master Control preferred
• 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
• Ability to travel between product storage facilities within Central and Northern Kentucky and Southern Ohio, and to Central Indiana, Texas, and vendor sites as needed

Core Competencies

Demonstrates expertise in validation lifecycle management, including authoring and executing validation protocols, conducting qualification studies, and ensuring compliance with FDA regulations and GMP guidelines. Proficient in data analysis, technical writing, and collaboration across departments to enhance validation and calibration processes.

Highest-signal resume keywords

• Validation Lifecycle Management
• Technical Writing
• Data Analysis
• GMP Compliance
• Calibration Management

ATS Optimization Keywords

Hard Skills

• Validation Protocol Authoring
• Qualification Studies
• Temperature Mapping
• Data Analysis
• Problem-Solving
• Technical Report Writing
• Regulatory Compliance
• Validation Documentation
• Quality System Documentation
• Project Management

Soft Skills

• Interpersonal Skills
• Communication Skills
• Collaboration
• Time Management
• Adaptability

Industry Keywords

• Pharmaceutical Validation
• Medical Device Validation
• Biotechnology
• GMP Guidelines
• FDA Regulations
• ISO 17025
• GAMP Principles
• Regulated Industry
• Validation Master Plans
• Management of Change

Tools & Technologies

• Kaye Validators
• Data Loggers
• Environmental Monitoring Systems
• Calibration Management Systems
• Electronic Quality Management Systems
• Microsoft Office