The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:

Bionova Scientific LLC

Job Description:

Bionova is actively seeking a highly motivated Maintenance and Calibration Technician to join our Facilities and Engineering team. This individual will play an important role in supporting the operation, maintenance, calibration, and compliance of Manufacturing, Laboratory, and Facilities systems within a GMP-regulated environment. The role requires experience with CMMS systems, equipment maintenance and troubleshooting, and quality documentation in support of clinical and commercial manufacturing. The ideal candidate will combine hands-on technical aptitude with a disciplined approach to quality compliance, vendor coordination, troubleshooting, and continuous improvement.

Bionova Scientific – Fremont, CA

Essential Responsibilities:

• 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 escalate 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.

Qualifications:

• 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.

Working Conditions:

This position is required to work in a GMP manufacturing facility, development laboratories, and office environment. The role requires walking, standing, stooping, kneeling, crouching, and climbing of ladders. The employee must occasionally lift and/or move up to 40 pounds independently.

The base compensation range for this role is $38-$50. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

#LI-MG1

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.