Maintenance & Calibration Technician – GMP/QA Focus

Asahi Kasei Bioprocess America, Inc.; Fremont (CA); Hybrid; USD 52,000 - 69,000; Full time

Job summary

Bionova Scientific, Inc. is seeking a Maintenance and Calibration Technician to join the Facilities and Engineering team in Fremont, CA. The role ensures calibration, maintenance, and compliance of GMP-regulated systems and coordinates with vendors for service and documentation.

The technician will document tasks in the CMMS, support QA and Manufacturing, and participate in after-hours maintenance and site shutdowns as needed. Strong attention to GMP processes and technical drawings is essential.

Qualifications

• Associate degree or technical certificate, military technical training, or equivalent experience in a scientific/technical field.
• Experience executing maintenance and calibration activities and using CMMS.
• Reading SOPs and technical specifications, and working from drawings.

Responsibilities

• Perform and support basic repairs, troubleshooting, preventive maintenance, and inspection of laboratory and manufacturing equipment and process instrumentation.
• Coordinate calibration of GMP and non-GMP instrumentation (temperature, pressure, humidity, flow, level, mass, pH, conductivity).
• Monitor, maintain, and troubleshoot HVAC, electrical, plumbing, gases, fire protection, and general facility systems.
• Coordinate with external vendors for maintenance, calibration, and repairs; obtain quotes, process POs, schedule visits, review vendor docs for GMP compliance.
• Document all maintenance and calibration tasks in the CMMS for audit readiness.
• Collaborate with Manufacturing, QA, Lab Operations, and Engineering to meet readiness timelines.
• Triage on-demand Facilities and Engineering work requests and create work orders.
• Develop maintenance infrastructure: Work Plans, Data Sheets, spare parts and inventory lists; submit change requests for asset data accuracy.
• Complete GMP-compliant records (work orders, calibration reverse traceability, maintenance docs); support root cause analyses and CAPAs.
• Monitor and escalate alarms and abnormal conditions to maintain reliability.
• Interpret drawings (P&IDs, wiring diagrams, schematics) and redline gaps as needed.
• Maintain OSHA-safe conditions and appropriate PPE; participate in after-hours work, shutdowns, and emergency maintenance.

Skills

Mechanical aptitude

Troubleshooting

Problem solving

CMMS experience

Calibration experience

Technical drawings reading

Education

Associate degree or technical certification

Tools

CMMS software

Job description

Bionova Scientific, Inc. is seeking a Maintenance and Calibration Technician to join the Facilities and Engineering team in Fremont, CA. The role ensures calibration, maintenance, and compliance of GMP-regulated systems and coordinates with vendors for service and documentation.

The technician will document tasks in the CMMS, support QA and Manufacturing, and participate in after-hours maintenance and site shutdowns as needed. Strong attention to GMP processes and technical drawings is essential.