Validation Engineer
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Position Summary:
The 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 Responsibilities:
Projects are located within greater Boston Massachusetts. Candidates must be able to travel to customer site to execute thermal distribution study protocols. Study Execution
Perform temperature and humidity mapping studies for CTUs including:
- Cold rooms, freezers, refrigerators
- Stability chambers
- IncubatorsExecute mapping protocols in accordance with approved procedures and validation plans
- Place and retrieve data loggers per defined grid patterns and risk-based placement strategies
- Support empty and loaded mapping studies, including seasonal qualification where required
- Instrumentation & Data Integrity
- Configure, program, and verify calibrated data loggers
- Perform pre- and post-deployment verification checks
- Maintain data integrity in alignment with 21 CFR Part 11 and ALCOA+ principles
- Data Analysis & Reporting
- Download, compile, and analyze mapping data using validated software tools
- Evaluate results against acceptance criteria (e.g., temperature range, uniformity, excursions)
- Identify worst-case sensor locations for ongoing monitoring
- Deviations and non-conformance documentation
- Ensure all documentation is audit-ready and compliant with GMP requirements
- Support change control, CAPA, and requalification activities as needed
- Interface with Quality Assurance for protocol/report approvals and deviations
- Regulatory & Technical Requirements
- Working 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)
Qualifications:
- EducationBachelor’s degree in Engineering, Life Sciences, or related technical field preferred
- Equivalent combination of education and relevant experience acceptable
- ExperienceMinimum 2–5 years of experience performing CTU temperature mapping in GMP environments
- Experience with validation/qualification documentation (IQ/OQ/PQ)
- Familiarity with pharmaceutical, biotech, or medical device regulated environments Technical Skills
- Proficiency with data logging systems and analysis software
- Strong understanding of calibration principles and measurement uncertainty
- Ability to interpret technical drawings, layouts, and validation protocols
Competencies:
- Strong attention to detail and data accuracy
- Ability to work independently in field environments
- Effective technical writing and documentation skills
- Problem-solving capability for environmental and equipment-related issues
- Clear communication with cross-functional teams (QA, Facilities, Operations)