Calibration Technician

Summary of Position: The Calibration Technician is responsible for inspecting, testing, calibrating, and maintaining measurement and test equipment to ensure accuracy and compliance with industry standards and company quality requirements. The Calibration Technician works closely with other departments to support the overall goals of the organization.

Physical Demands & Work Conditions

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Must be comfortable regularly participating in video-based meetings.

Key Responsibilities:

• Perform calibration, adjustment, and repair of equipment used in GMP Production and Quality Control Lab testing (mechanical, electrical, electronic, and dimensional).
• Maintain calibration records in accordance with quality standards (ISO, ANSI, NIST, etc.).
• Utilize and maintain a Computerized Maintenance Management System (CMMS) to accurately track, plan, and document asset calibration, repairs, and inventory, ensuring data integrity for regulatory compliance.
• Troubleshoot equipment performance issues and recommend corrective actions.
• Ensure all Calibration Standards meet required tolerances and specifications.
• Author and update calibration procedures.
• Assist with internal and external audits.
• Maintain a clean and organized calibration lab.
• Coordinate with production and engineering teams to minimize downtime.

Qualifications:

• Associate degree or technical certification in Electronics, Engineering Technology, or related field (or equivalent experience).
• 4 years of calibration experience in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical manufacturing facility.
• Strong knowledge of measurement principles and standards (ISO 9001, ISO/IEC 17025 preferred).
• Experience with Calibration Standards such as multimeters, temperature sensors pressure gauges, torque tools, tachometers, calipers, and other precision instruments.
• Experience with GMP regulatory standards, and documenting work per GDP requirements.
• Ability to read technical drawings and schematics.
• Strong attention to detail, documentation, communication, and interpersonal skills.
• Proficiency in Microsoft Office, maintenance management, and calibration management software.
• Familiarity with NIST traceability requirements.
• Strong problem-solving and analytical skills.
• Ability to work independently and as part of a team.
• The position requires on-site presence and typically involves regular hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response.
• Gowning for cleanroom access.
• Ability to lift up to 40 lbs.
• Manual dexterity for handling small components.