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Senior Recruiter at Staftonic, Passionate about connecting great people with great opportunities
Location: Massachusetts
Long Term Project
Key Responsibilities
- 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 .
- Calibrate, deploy, and retrieve data loggers or sensors, ensuring accurate data collection.
- Analyze and interpret temperature mapping data; prepare comprehensive validation reports .
- 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 .
- Collaborate with Quality, Engineering, and Operations teams to support audits and inspections.
- Maintain up-to-date knowledge of validation best practices and regulatory requirements.
Qualifications
- 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 .
- Hands-on experience with data loggers, thermal probes, and validation software .
- Strong understanding of GxP, cGMP, and regulatory compliance .
- Excellent documentation, analytical, and problem-solving skills.
- Ability to manage multiple projects and meet strict timelines.