Validation Engineer

Position SummaryThe Temperature Mapping Specialist is responsible for execution of temperature and humidity mapping studies for Controlled Temperature Units (CTUs) in compliance with applicable regulatory requirements and industry standards through out greater Boston Massachusetts. This role supports qualification (IQ/OQ/PQ), requalification, and routine monitoring verification activities across GMP-regulated environments including pharmaceutical, biotechnology, and distribution operations. The position requires technical expertise in thermal mapping methodologies, data acquisition systems, and regulatory expectations (e.g., FDA, ICH, USP) to ensure that CTUs operate within validated ranges and maintain product quality.Key ResponsibilitiesProjects are located within greater Boston Massachusetts. Candidates must be able to travel to customer site to execute thermal distribution study protocols. Study ExecutionPerform temperature and humidity mapping studies for CTUs including:Cold rooms, freezers, refrigeratorsStability chambersIncubatorsExecute mapping protocols in accordance with approved procedures and validation plansPlace and retrieve data loggers per defined grid patterns and risk-based placement strategiesSupport empty and loaded mapping studies, including seasonal qualification where requiredInstrumentation & Data IntegrityConfigure, program, and verify calibrated data loggersPerform pre- and post-deployment verification checksMaintain data integrity in alignment with 21 CFR Part 11 and ALCOA+ principlesData Analysis & ReportingDownload, compile, and analyze mapping data using validated software toolsEvaluate results against acceptance criteria (e.g., temperature range, uniformity, excursions)Identify worst-case sensor locations for ongoing monitoringDeviations and non-conformance documentationEnsure all documentation is audit-ready and compliant with GMP requirementsSupport change control, CAPA, and requalification activities as neededInterface with Quality Assurance for protocol/report approvals and deviationsRegulatory & Technical RequirementsWorking knowledge of:FDA 21 CFR Parts 210, 211, and 11ICH Q1A (Stability Testing)USP <1079> (Good Storage and Distribution Practices)ISPE Good Practice Guides (Cold Chain Management, CTU qualification)QualificationsEducationBachelor’s degree in Engineering, Life Sciences, or related technical field preferredEquivalent combination of education and relevant experience acceptableExperienceMinimum 2–5 years of experience performing CTU temperature mapping in GMP environmentsExperience with validation/qualification documentation (IQ/OQ/PQ)Familiarity with pharmaceutical, biotech, or medical device regulated environments Technical SkillsProficiency with data logging systems and analysis softwareStrong understanding of calibration principles and measurement uncertaintyAbility to interpret technical drawings, layouts, and validation protocolsCompetenciesStrong attention to detail and data accuracyAbility to work independently in field environmentsEffective technical writing and documentation skillsProblem-solving capability for environmental and equipment-related issuesClear communication with cross-functional teams (QA, Facilities, Operations)