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.
• Collaborate closely with process engineers, quality assurance, and manufacturing staff to ensure seamless operations.
• Resolve current issues in a timely manner, while proactively documenting root causes and recommending long-term solutions to prevent recurrence.

Job Requirements:

Education Minimum of 6-8 years relevant maintenance experience and Minimum of 6-8 years relevant maintenance experience and High School diploma or equivalent required. Associate or bachelor’s degree in a related field is a plus.

Experience Minimum of 6 years’ experience performing mechanical in both process areas and in a laboratory environment. Minimum of 4 years’ experience within a GMP and/or other highly regulated environment

Technical Skills Experience with CMMS platforms, such as Indysoft, SAP PM, Maximo or other CMMS platforms preferred.

Non-Technical Skills Ability to work collaboratively with our clients to promote excellence in customer service. Strong communication and organizational skills. Excellent attention to detail and data integrity. 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. This is not a hybrid or remote role.

Working Conditions:

Requires up to 5% of domestic travel. This role will initially follow a Monday–Friday day shift during construction and commissioning. Once production begins, the schedule will transition to a 2-2-3 day shift, as needed. Must be able to lift up to 50 lbs. unassisted. Exposure to machinery, noise, and physical hazards (with appropriate PPE provided). Requires the ability to frequently perform work while bending, stooping, reaching overhead, and repetitive hand dexterity and mobility.

The anticipated salary for this position will be $43.22 to $50.38. 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.

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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.

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