Biotech and Pharmaceutical, Calibration, Code of Federal Regulations, Documentation, Electricity, Electronics, Equipment Maintenance/Repair, FDA (Food and Drug Administration), FDA Requirements, Failure Analysis, ISO (International Organization for Standardization), Identify Issues, Instrumentation, Laboratory Equipment, Maintain Compliance, Medical Equipment, Metrology, On Site Support, Outsourcing, Preventative Maintenance, Quality Management, Quality System Requirements (QSR), Root Cause Analysis, SAP, Technical Drawing, Test & Measurement Equipment, Test Equipment, Time Management, Traceability, U.S. National Institute of Standards and Technology (NIST)
Position Summary
The Calibration Technician is responsible for performing calibration, maintenance, and documentation of inspection, measurement, and test equipment (IM&TE) to ensure compliance with BD Quality System requirements, FDA regulations (21 CFR Part 820), and ISO 13485 standards.
This role supports both internal laboratory equipment and field service equipment, with a focus on reducing calibration backlog, maintaining equipment readiness, and supporting audit readiness activities.
Key Responsibilities
1. Calibration Execution (Core Function)
- Perform calibration, verification, and adjustment of IM&TE including:
- Electrical, mechanical, and dimensional equipment (e.g., Mettler balances, Instron systems, calipers, multimeters)
- Execute calibrations in accordance with:
- Approved procedures, work instructions, and specifications
- Manufacturer requirements and traceability standards
- Evaluate calibration results for:
- Out-of-tolerance (OOT) conditions
- Measurement uncertainty and acceptability criteria
2. Field Service Equipment Support
- Support calibration and control of field service and portable equipment
- Ensure proper tracking, calibration status, and labeling prior to deployment
- Coordinate with Field Service teams to:
- Maintain compliance for equipment used in customer environments
- Resolve calibration-related issues impacting service operations
3. Documentation & Compliance
- Accurately document calibration results in BD systems (e.g., BMRAM or equivalent)
- Maintain complete and audit-ready records, including:
- Calibration certificates
- Traceability to national/international standards (NIST, ISO)
- Initiate and support investigations for:
- Out-of-tolerance conditions
- Calibration discrepancies or failures
4. Calibration Scheduling & Coordination
- Support execution of calibration schedules to meet due dates and reduce backlog
- Interface with internal stakeholders and external vendors for:
- Outsourced calibration activities
- Equipment service and repair
- Ensure timely turnaround of equipment to minimize operational impact
5. Equipment Maintenance & Troubleshooting
- Perform basic troubleshooting, repair coordination, and preventive maintenance
- Identify equipment performance issues and escalate as needed
- Support root cause analysis for calibration failures or recurring issues
Qualifications
Minimum Requirements
- Degree or relevant certifications preferred, but not required
- Electronics, Mechanical Technology, Metrology, or related field OR equivalent experience
- 3+ years of experience in calibration, metrology, or test equipment maintenance
- Hands-on experience calibrating IM&TE in a regulated environment
Preferred Qualifications
- Experience in medical device, biotech, or pharmaceutical industry
- Familiarity with:
- FDA 21 CFR Part 820
- ISO 13485 requirements
- Experience with calibration and quality management systems (e.g., BMRAM, SAP, GAGEtrak)
- Knowledge of:
- Measurement uncertainty
- Root cause analysis and OOT investigations
Technical Skills
- Strong understanding of:
- Measurement science and calibration techniques
- Electrical and mechanical instrumentation
- Ability to read and interpret:
- Technical drawings, specifications, and procedures
- Proficiency with standard test equipment:
- Multimeters, pressure gauges, scales, force testers, dimensional tools