Senior Validation Engineer — GMP, Data Analysis & Calibration

Jobtailor; Kentucky; On-site; USD 75,000 - 110,000; Full time

Job summary

Jobtailor is seeking a dedicated validation professional to support the Validation Manager in administering the site Validation Program. You will author and review validation documentation across the lifecycle, including DQ/IQ/OQ/PQ, temperature mapping, and requalification reports, while coordinating qualification activities for facilities, utilities, and equipment.

The role requires collaboration with Operations, Facilities, QA, and external providers, plus support for audits and regulatory

Qualifications

• 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 MasterControl preferred
• Knowledge of FDA regulations, EU GMP guidelines, GAMP principles, and validation lifecycle methodologies
• Understanding of calibration requirements and applicable standards, including ISO 17025

Responsibilities

• Support the Validation Manager in administering and continuously improving the site Validation Program
• Author, execute, review, and maintain validation lifecycle documentation (DQ/IQ/OQ/PQ, temperature mapping, requalification protocols, 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 for validated systems
• Conduct data collection, analysis, and technical evaluations to determine acceptance of validation studies
• Coordinate calibration activities for temperature monitoring devices, data loggers, sensors, and other measuring equipment
• Review calibration and maintenance records to ensure equipment remains qualified and compliant
• Assist with developing and maintaining Validation Master Plans, validation procedures, and related quality system documentation
• Collaborate with Operations, Facilities, Quality Assurance, and external 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

Skills

Technical writing

Data analysis

Regulatory compliance

Project management

Collaboration

Communication skills

Time management

Adaptability

Interpersonal skills

Problem solving

Education

Bachelor's degree in Engineering, Life Sciences, Quality or related technical discipline

Tools

Kaye Validators

Data loggers

Environmental monitoring systems

Calibration management systems

Electronic quality management systems

Microsoft Office

Job description

Jobtailor is seeking a dedicated validation professional to support the Validation Manager in administering the site Validation Program. You will author and review validation documentation across the lifecycle, including DQ/IQ/OQ/PQ, temperature mapping, and requalification reports, while coordinating qualification activities for facilities, utilities, and equipment.

The role requires collaboration with Operations, Facilities, QA, and external providers, plus support for audits and regulatory