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:

The Sr. 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, maintenance spare parts, deviations, change controls, CAPAs and other duties as assigned, to ensure compliance, data integrity, and 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.
•    Control and manage spare part inventory utilizing the CMMS and our ERP system (D365).

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.
•    Represent the maintenance department in critical investigations as required.  
•    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
5-7 years’ experience working within a CMMS environment preference given to those with SAP or Microsoft Dynamic experience.
 5-7 years relevant experience with a CMMS, EDMS, authoring and supporting deviations, and change controls.
Experience managing spare parts

Technical Skills
Experience with CMMS platforms, such as D365 EAM, SAP PM, Maximo or other CMMS platforms preferred. Experience with an EDMS (preferably Adept).   Experience authoring and participating in investigations and associated corrective actions. 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.

Physical Demands:

Initially working on a construction site and ultimately in a biotech
manufacturing site in Sanford, NC. Work is 100% on-site. This is not a hybrid or remote role.

Working Conditions:

May require up to 5% of domestic travel. Long periods of standing and sitting required. Exposure to machinery, noise, and physical hazards (with proper PPE).

The anticipated salary for this position will be $41.78/hr to $44.00/hr.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.