Maintenance Specialist

Kyowa Kirin, Inc.- U.S.; Sanford (NC); On-site; USD 34,000 - 48,000; Full time

Benefits offered by this job

401K with company matching

Annual Bonus Program

Generous PTO & holidays

Healthcare Benefits

HSA & FSA programs

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Kyowa Kirin North America seeks a Maintenance Specialist to support GMP-regulated facilities in Sanford, NC. You will manage CMMS/EDMS, ensure data integrity, and coordinate maintenance activities for critical equipment and infrastructure.

As an individual contributor, you will collaborate across teams, uphold 21 CFR Part 11 compliance, and drive improvements in asset records, PM schedules, and maintenance history while supporting audits and regulatory needs.

Qualifications

• 2–4 years of CMMS experience required, SAP or Microsoft Dynamics preferred.
• Experience with CMMS platforms and EDMS; knowledge of deviations and change controls.
• Detail-oriented with strong data integrity and regulatory awareness.

Responsibilities

• Administer and maintain CMMS for preventive, corrective, and predictive maintenance.
• Administer EDMS for document control of building and equipment.
• Develop asset records, PM schedules, work orders, and maintenance history.
• Collaborate with IT and vendors to troubleshoot issues and implement improvements.
• Generate reports and KPIs; schedule calibrations and vendor PMs.
• Support deviations, change controls, CAPA, and regulatory audits.

Skills

CMMS admin

EDMS mgmt

Asset records

PM scheduling

Reports & KPIs

Vendor support

GMP knowledge

21 CFR Part 11

Education

High School diploma

Associate or bachelor's degree preferred

Tools

D365 EAM

SAP PM

Maximo

Adept EDMS

Job description

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 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 promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

Physical Demands

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

Working Conditions

Requires up to 5% of domestic travel. Exposure to machinery, noise, and physical hazards (with proper PPE).

The anticipated salary for this position will be $25.00/hr to $35.00/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.

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.

LI-TT1 #On-Site #Sanford #North Carolina