POSITION

Field Calibration Technician

COMPANY AND LOCATION

Stratum Analytical, Oshawa, ON

EMPLOYMENT TYPE

Permanent, Full Time

HOURS WORKED

37.5 hours/week

DIRECT REPORTS

No

POSITION SUMMARY:

The Field Calibration Technician will collaborate closely with the Quality & Compliance Technician to support coordination and execution of both internal and client-facing calibration, qualification, validation, and compliance activities. The role’s activities primarily focus on lifecycle maintenance of controlled temperature equipment but also include other laboratory equipment as required. These activities include but not limited to calibration, qualification, temperature mapping and validation studies. These tasks will involve travel to client facilities, preparation of technical reports, and support of quality investigations. The technician is expected to cultivate and maintain a thorough understanding of relevant standards and regulations, including ISO/IEC 17025, Good Manufacturing Practices (GMP), Valuable Documentation Practices (GDP), data integrity requirements, and pharmaceutical and healthcare storage guidelines.

GENERAL RESPONSIBILITIES & ESSENTIAL FUNCTIONS

Calibration

- Coordinate calibration-related activities for controlled temperature equipment, ensuring all procedures comply with relevant requirements, including ISO/IEC 17025, ISO/IEC 9001, and ICH.
- Perform calibrations and verifications on controlled temperature equipment including refrigerators, freezers, ultra-low freezers, incubators, stability chambers, environmental chambers, ovens, autoclaves, warehouses, storage areas, and cold chain equipment.




- Ensure all calibrations are traceable to recognized national or international measurement standards (e.g., SI).
- Prepare documentation required for testing, including but not limited to work orders, worksheets, and laboratory reports.
- Create and maintain standard operating procedures (SOPs) and controlled documents for equipment maintenance and calibration.

Equipment Qualification & Validation

- Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment, focusing primarily on controlled temperature systems.
- Conduct temperature mapping, thermal distribution, and environmental monitoring studies.
- Support the onboarding and continuous validation of laboratory equipment, especially where expertise in traceability is required.
- Prepare written protocols, validation reports, and risk assessments.
- Set predefined acceptance criteria, analyze data, and evaluate compliance.
- Assist in the development and validation of monitoring systems and data acquisition systems.

- Support investigations and documentation related to equipment failures, excursions, deviations, and non-conformances.

Equipment Lifecycle Management

- Coordinate calibration, qualification, preventative maintenance,



and service activities for laboratory instrumentation and associated systems.
- Maintain equipment files including specifications, qualification records, calibration certificates, maintenance records, and validation documents.
- Coordinate external service providers and vendors as required.
- Review vendor documentation for compliance with applicable standards and quality requirements.

Client Services & Field Work

- Travel to client facilities to perform calibration, qualification, validation, and temperature mapping activities.
- Represent Stratum Analytical professionally while performing on-site services.
- Proactive communication to customers when responding to inquiries, project amendments, issues, concerns and complaints.
- Clear communication to customers through phone, email, or in-person.
- Coordinate project timelines and testing activities with client personnel.
- Communicate project updates, findings, deviations, and recommendations to clients.

Quality Systems & Compliance

- Work collaboratively with the Quality & Compliance Technician to plan and execute both internal and client projects.
- Ensure all activities comply with applicable quality standards, accreditation requirements, and regulatory expectations.
- Participate in internal audits, external audits, accreditation assessments, and client inspections.
- Review and maintain Standard Operating Procedures (SOPs), forms, protocols, and quality documents.
- Support corrective and preventive action (CAPA) investigations.
- Follow Good Documentation Practices and maintain accurate, contemporaneous records.
- Promote a culture of quality, co

📌 Field Calibration Technician (Oshawa)
🏢 Auxilium Health
📍 Oshawa