Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.

Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.

Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.

We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com.

Summary of Job:

The Lead Maintenance and Utility Technician will manage maintenance operations at our biopharmaceutical manufacturing facility. The ideal candidate will possess strong knowledge of GMP (Good Manufacturing Practices), facility and equipment maintenance, and regulatory compliance. This role is critical to ensuring the reliable operation of essential systems, minimizing downtime, and supporting a clean, compliant production environment.

As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

Essential Functions

Technical

Perform scheduled inspections and preventive maintenance on bioprocessing equipment (e.g., bioreactors, centrifuges, filtration units).
Diagnose equipment malfunctions and execute timely, effective repairs.
Actively support the installation and startup of new equipment, ensuring seamless integration with control systems (PLC, SCADA, DCS); assist with mechanical installation and qualification activities.
Coordinate maintenance activities with internal stakeholders (e.g., manufacturing and laboratory teams) to minimize operational disruptions.
Maintain accurate records to support audits and ensure compliance with GMP (Good Manufacturing Practices) and FDA regulations.
Coordinate maintenance activities with internal and external stakeholders (e.g., manufacturing and laboratory teams) to minimize disruptions and escalate issues promptly when necessary.
Collaborate closely with process engineers, quality assurance, and manufacturing staff to ensure seamless operations.
Demonstrate a strong commitment to quality, safety, and compliance.

Administrative

Maintain accurate records to support audits and ensure compliance with GMP (Good Manufacturing Practices) and FDA regulations.
Coordinate maintenance activities with internal and external stakeholders (e.g., manufacturing and laboratory teams) to minimize disruptions and escalate issues promptly when necessary.