Maintenance Specialist

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 . Summary The Maintenance Specialist will support our facilities and maintenance operations in a GMP-regulated life sciences environment. The ideal candidate will be responsible for managing the CMMS, EDMS and assisting with other duties as assigned, to ensure compliance, data integrity, and the efficient scheduling and tracking of maintenance activities for critical equipment and infrastructure. 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 Skills Administer and maintain the Computerized Maintenance Management System (CMMS) to support preventive, corrective, and predictive maintenance programs. Administer and maintain the Engineering Document Management System (EDMS) to support our control and custody of all documents related to the building and equipment. Develop, update, and manage asset records, PM schedules, work orders, and maintenance history in the CMMS. Work with IT and CMMS/EDMS vendors to troubleshoot technical issues and implement improvements. Generate periodic reports and KPIs related to maintenance performance, equipment reliability, and compliance. Schedule calibrations, maintenance, and vendor PMs Maintain data integrity with new assets, moves, and retirements. Administrative Provide software training to end users and new administrators and serve as a liaison for problem-solving and escalation Lead or participate in system upgrades, validation, and configuration changes, ensuring compliance with 21 CFR Part 11 and other relevant regulations. Author and support deviations, change controls and CAPA's for the maintenance department. Support regulatory audits by providing documentation, maintenance history reports, and CMMS/EDMS data as needed. Requirements Education High School diploma or equivalent required. Associate or bachelor's degree preferred. Experience 2-4 years experience working within a CMMS environment preference given to those with SAP or Microsoft Dynamic experience. 2-4 years relevant experience with a CMMS, EDMS, authoring and supporting deviations, and change controls. Technical Skills Experience with CMMS platforms, such as D365 EAM, SAP PM, Maximo or other CMMS platforms preferred. Experience with an EDMS (preferably Adept). Ability to work collaboratively with our clients to promote excellence in customer service. Ability to import data, create templates and export data as required is a plus. Ability to generate reports and modify reports as needed. Strong communication and organizational skills. Excellent attention to detail and data integrity. Non-Technical Skills Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond pr #J-18808-Ljbffr kyowakirinusa90