GMP Calibration Technician — On-Site, Equity Eligible

Orca Bio; San Diego (CA); On-site; USD 38,572 - 44,083; Full time

Benefits offered by this job

On-site meals

Annual bonus

Pre-IPO equity

Job summary

Orca Bio in San Diego, CA is seeking a Calibration Technician to inspect, test, calibrate, and maintain measurement equipment for GMP Production and Quality Control. You will document calibrations, troubleshoot issues, and support audits to uphold ISO standards.

Requirements include a 4-year GMP calibration background, reading schematics, and strong attention to detail. On-site role with potential on-call hours; lifting up to 40 lbs and cleanroom gowning are required.

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.

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.

Skills

GMP experience

Attention to detail

Documentation

Analytical thinking

Reading schematics

Team collaboration

Cleanroom readiness

Problem solving

Independent work

Education

Associate degree or technical certification in Electronics or Engineering Technology

Tools

Multimeters

Temperature sensors

Pressure gauges

Torque tools

Tachometers

Calipers

Job description

Orca Bio in San Diego, CA is seeking a Calibration Technician to inspect, test, calibrate, and maintain measurement equipment for GMP Production and Quality Control. You will document calibrations, troubleshoot issues, and support audits to uphold ISO standards.

Requirements include a 4-year GMP calibration background, reading schematics, and strong attention to detail. On-site role with potential on-call hours; lifting up to 40 lbs and cleanroom gowning are required.