Validation Engineer; Temperature Mapping

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Direct message the job poster from Staftonic LLC

Location: Massachusetts

Long Term Project

• Plan and execute temperature mapping studies for controlled areas, warehouses, cold rooms, refrigerators, freezers, and transport systems.
• Develop and review validation protocols, including IQ, OQ, PQ, and mapping protocols
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• Calibrate, deploy, and retrieve data loggers or sensors, ensuring accurate data collection.
• Analyze and interpret temperature mapping data; prepare comprehensive validation reports
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• Identify excursions, deviations, and implement corrective and preventive actions (CAPA).
• Ensure validation documentation complies with 21 CFR Part 11, EU Annex 15, WHO, and ICH guidelines
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• Collaborate with Quality, Engineering, and Operations teams to support audits and inspections.
• Maintain up-to-date knowledge of validation best practices and regulatory requirements.

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3–5 years of experience in pharmaceutical or biopharmaceutical validation, with strong focus on temperature mapping
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• Hands-on experience with data loggers, thermal probes, and validation software
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• Strong understanding of GxP, cGMP, and regulatory compliance
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• Excellent documentation, analytical, and problem-solving skills.
• Ability to manage multiple projects and meet strict timelines.