Validation Engineer (Temperature Mapping)

Staftonic LLC; Massachusetts; Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

A leading company in validation services is seeking a Senior Recruiter with expertise in temperature mapping studies. You will plan and execute temperature mapping for various controlled areas and ensure compliance with regulatory standards. The ideal candidate has a Bachelor’s degree in a related field and 3–5 years of relevant experience, demonstrating excellent analytical and problem-solving skills.

Qualifications

• 3–5 years of experience in pharmaceutical or biopharmaceutical validation focused on temperature mapping.
• Hands-on experience with data loggers and validation software.
• Strong understanding of GxP, cGMP, and regulatory compliance.

Responsabilités

• Plan and execute temperature mapping studies for controlled areas.
• Develop and review validation protocols, including IQ, OQ, PQ.
• Analyze and interpret temperature mapping data; prepare validation reports.

Connaissances

Temperature mapping studies

Validation protocols

Data loggers

Regulatory compliance

Problem-solving skills

Formation

Bachelor’s degree in Engineering, Life Sciences, or related field

Outils

Validation software

Thermal probes

Description du poste

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Staftonic LLC

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.