Field Calibration Technician

#LI-DNI JOB DESCRIPTION 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), Good 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, compliance, and continuous improvement.

QUALIFICATIONS Experience with database administration and good organizational skills Ability to multitask and work effectively in a fast-paced environment Excellent verbal communication skills Ability to effectively communicate complex analytical information to non- specialists Ability to read, understand and comply with company policies and SOPs, including safety rules and regulations General understanding of laboratory processes is strongly recommended.

Valid G driver’s licence and access to a vehicle, as required.

EDUCATION Bachelor’s degree or advanced diploma in a field related to engineering, engineering technology, instrumentation, or science; or relevant industry experience.

Equivalent combination of education, training, and industry experience may be considered.

COMPLIANCE KNOWLEDGE ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories.

ISO/IEC 9001 Quality Management Systems.

Good Manufacturing Practices (GMP) and applicable pharmaceutical regulations.

Good Documentation Practices (GDP).

Data Integrity principles including ALCOA+.

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) principles.

Temperature mapping and controlled environment qualification standards.

Metrological-traceability and best practices for calibrations.

Applicable CSA, ANSI, ASTM, ASHRAE, and ISO/IEC standards relevant to controlled environments and calibration activities.

Accreditation and audit requirements associated with laboratory operations, equipment qualification, and calibration services.

SPECIFIC WORKING CONDITIONS OR PHYSICAL REQUIREMENTS: Work may be performed in the on-site office or laboratory setting as well as in various off-site facilities.

Therefore, the Field Calibration Technician needs to be able to transport themselves between worksites.

Extended periods of sitting at a desk for data entry or standing while managing samples may be necessary.

Fine motor skills and manual dexterity for tasks such as handling delicate equipment, precision manipulation of equipment, and documentation.

Due to the nature of temperature-controlled equipment, excursions and deviations occur sporadically and may happen after normal working hours.

The individual would be required to respond to alerts after normal working hours and on weekends.

• ---------- DISCLAIMER: The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.

Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.

OUR RECRUITMENT PROCESS: Application and Questionnaire - Candidates submit an application and complete the initial questionnaire.

Pre-Screen Video Interview - Qualified candidates will be invited within one week to complete a short one-way video pre-screen.

In-Person Interview - Shortlisted candidates will be invited to attend an in-person interview at our head office.

Offer and Background Check - The successful candidate will be offered the position, pending a criminal background check and references.

We appreciate the applications from all candidates, but only those selected for the next steps will be contacted.

Stratum Analytical is an equal opportunity employer.

We welcome diversity and are committed to creating an inclusive environment for all employees.

Accommodations are available on request for candidates taking part in all aspects of the selection process.

As our company continues to grow, we’re excited to welcome a Field Calibration Technician to our team.

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