Calibration Technician

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.