GMP Maintenance & Calibration Technician

Celgard; Fremont (CA); In loco; USD 52.000 - 69.000; Tempo pieno

Vantaggi offerti da questo lavoro

Descrizione del lavoro

Bionova Scientific LLC in Fremont, CA, is seeking a Maintenance and Calibration Technician to join our Facilities and Engineering team in a GMP environment. You will support maintenance, calibration, and compliance of manufacturing, lab, and facilities systems, with CMMS documentation and vendor coordination.

The ideal candidate has 1–4 years of technical maintenance experience, strong mechanical skills, ability to read drawings, SOP adherence, and a disciplined approach to GMP documentation;

Competenze

• Associate degree, technical certificate, military technical training, trade school education, or equivalent experience in a scientific, technical, engineering, maintenance, or related discipline.
• 1–4 years of experience supporting facility operations, maintenance, calibration, manufacturing equipment, laboratory equipment, or related technical systems.
• Strong mechanical aptitude, troubleshooting, and problem-solving skills.
• Experience executing maintenance and calibration activities and using Computerized Maintenance Management Systems (CMMS).
• Experience following Standard Operating Procedures (SOPs), reading equipment drawings (e.g. P&IDs, wiring diagrams), and working from technical specifications.
• Basic understanding of mechanical and electrical systems used in laboratory, manufacturing, and facility equipment.
• Ability to independently prioritize work and manage multiple assignments.
• Attention to detail and commitment to accurate maintenance, calibration, and GMP documentation.
• Experience using Microsoft Office or similar software and completing technical documentation.
• Preferred: Experience within the biopharmaceutical, pharmaceutical, or other regulated industry.
• Working knowledge of GMP (Good Manufacturing Practices) and regulatory compliance requirements.
• Experience using building automation systems, facility management software, or other computerized monitoring systems.
• Experience coordinating with external service providers and reviewing maintenance and calibration documentation.
• Experience using AI-assisted tools such as Microsoft Copilot to support maintenance troubleshooting, technical documentation, and problem solving.

Mansioni

• Perform and support basic repairs, troubleshooting, preventive maintenance, and inspection of laboratory and manufacturing equipment and process instrumentation.
• Perform and/or coordinate calibration of GMP and non-GMP instrumentation, including but not limited to the following parameters: temperature, pressure, humidity, flow, level, mass, pH, and conductivity devices.
• Monitor, maintain, and troubleshoot critical utilities and building systems, including HVAC, electrical, plumbing, gases, fire protection, and general facility infrastructure.
• Coordinate with external vendors for maintenance, calibration, and repairs beyond internal capabilities, including obtaining quotes and processing POs for service, scheduling on-site visits, shipping equipment off-site, and reviewing vendor documentation for completeness and GMP compliance.
• Document all maintenance‑and‑calibration-related tasks in the CMMS, ensuring timely completion and audit readiness.
• Work closely with Manufacturing, QA, Lab Operations, and Engineering teams to meet business needs and equipment readiness timelines.
• Support triage of on‑demand Facilities and Engineering Work Requests and creation of Work Orders as necessary.
• Actively participate in development and continuous improvement of Maintenance and Calibration infrastructure by developing Work Plans, Measurement Data Sheets and spare parts and inventory lists, and submitting change requests to maintain the accuracy of asset information in the CMMS.
• Complete and review GMP‑compliant records including work orders, calibration reverse traceability reports, and maintenance documentation. Support root cause analyses, investigations, change control actions, work instruction revisions, and CAPAs as required.
• Monitor, respond to, troubleshoot, and appropriately escalation equipment, utility, laboratory, and facility alarms and abnormal conditions to maintain system reliability and operational readiness.
• Interpret and work from technical drawings including P&IDs, wiring diagrams, and schematics. Redline and communicate gaps as necessary.
• Maintain safe working conditions by following OSHA and internal safety procedures and wearing appropriate PPE.
• Participate in after‑hours support, site shutdowns, and emergency maintenance as required.
• Other duties and responsibilities as assigned.

Conoscenze

Mechanical aptitude

Troubleshooting

CMMS experience

SOPs knowledge

Documentation

Microsoft Office

Formazione

Associate degree or technical certificate

Strumenti

CMMS software

MS Office

Descrizione del lavoro

Bionova Scientific LLC in Fremont, CA, is seeking a Maintenance and Calibration Technician to join our Facilities and Engineering team in a GMP environment. You will support maintenance, calibration, and compliance of manufacturing, lab, and facilities systems, with CMMS documentation and vendor coordination.

The ideal candidate has 1–4 years of technical maintenance experience, strong mechanical skills, ability to read drawings, SOP adherence, and a disciplined approach to GMP documentation;