Controlled Temperature Equipment Validation Engineer; CTE

Controlled Temperature Equipment Validation Engineer (CTE)
Foster City, CA (Onsite 5 days a week)
Long Term Rolling Contract

Job Description:

A Controlled Temperature Equipment Validation Engineer ensures that thermal equipment (freezers, incubators, chambers) operates within strict GxP/FDA regulations. Key duties include developing/executing IQ/OQ/PQ protocols, performing temperature mapping studies, documenting, and maintaining compliance for equipment, ensuring consistent, reliable performance.

Key Responsibilities and Duties:

• Protocol Development & Execution:
  Drafts, reviews, and executes Validation Master Plans, User Requirement Specifications (URS), and IQ/OQ/PQ protocols for new and existing equipment.
• Temperature Mapping:
  Conducts thermal mapping of cold rooms, freezers, refrigerators, incubators, and stability chambers to ensure uniformity and compliance.
• Data Analysis & Reporting:
  Uses data loggers (e.g., Ellab) to analyze, document, and report on mapping studies and validation results.
• Regulatory Compliance:
  Ensures all activities comply with FDA, EMA, ICH, and ISO standards.
• Deviation & Change Control:
  Supports quality systems by managing deviations, investigations, CAPA, and change controls related to equipment.
• Collaboration:
  
  Coordinates with Quality Assurance, Facilities, and Manufacturing to maintain a validated state.
• perform qualification of controlled temperature equipment (CTE) including stability chambers, freezers ( 20/80 Degrees Celsius), cold rooms, refrigerators, and warehouses
• Develop, execute, and report IQ/OQ/PQ and temperature mapping protocols in compliance with GMP and regulatory requirements
• Ensure CTE systems support clinical and/or commercial product storage and stability programs
• Analyze temperature data, identify excursions, and support deviation investigations and CAPAs
• Support requalification, periodic reviews, and change control activities for temperature-controlled systems
• Coordinate with Quality and Engineering
• Maintain qualification documentation in alignment with internal SOPs and regulatory expectations (FDA, EU, ICH)
• Support audits and inspections related to CTE qualification and temperature control compliance

• Experience:
  
  Previous experience in validation, specifically in thermal mapping and environmental control.
• Knowledge:
  Strong understanding of cGMP/GxP regulations.
• Technical
  
  Skills:
  
  Proficiency with data loggers and Microsoft Office/Project.

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.