Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist working from drug discovery to product development and North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.
As the Senior Maintenance and Utilities Technician this role ensures the reliable operation and maintenance of facility utilities and equipment at our biopharmaceutical manufacturing site by applying advanced expertise in GMP regulatory compliance and technical troubleshooting. You manage complex projects mentor other technicians and implement best practices to enhance team performance and efficiency. By proactively addressing maintenance needs and minimizing downtime you maintain a clean safe and 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 organizations 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.
This role reports into the Manager Maintenance and Utilities
Technical Skills Knowledge and Experience
Perform scheduled inspections preventive maintenance and corrective repairs on bioprocessing equipment such as bioreactors centrifuges and filtration units to ensure optimal performance and reliability.
Execute preventive and corrective maintenance on facility utilities including boilers chillers air compressors WFI water systems HVAC systems and other critical infrastructure as required.
Proactively diagnose complex equipment malfunctions conduct timely repairs and implement long-term solutions to prevent recurrence; escalate unresolved or critical issues to appropriate management or technical experts providing clear documentation and recommendations.
Demonstrate a strong commitment to safety by adhering to all Environmental Health and Safety (EHS) policies and proactively identifying and mitigating potential hazards.
Provide technical support for the start-up commissioning and turnover of new systems throughout the site ensuring seamless integration and compliance.
Maintain accurate and comprehensive maintenance records in compliance with GMP (Good Manufacturing Practices) FDA regulations and audit requirements.
Collaborate closely with process engineers quality assurance manufacturing staff and other cross-functional teams to resolve technical issues and support operational goals.
Mentor and provide technical guidance to other technicians and contractors fostering knowledge sharing and professional development.
Document root causes of equipment failures and recommend effective long-term solutions to enhance reliability and efficiency.
Plan and execute site shutdowns effectively ensuring minimal disruption to operations while maintaining safety compliance and schedule adherence.
Individual contributor with responsibility to lead or work with cross-functional project teams.
Education
High school diploma or equivalent with a minimum demonstrated 35 years of relevant cGMP maintenance experience.
An associate or bachelors degree in a related field (such as engineering technology mechanical engineering or industrial maintenance) is preferred and may substitute for some experience.
Experience
Minimum demonstrated 35 years of hands-on experience working within a GxP or other highly regulated environment.
Technical Skills
Demonstrate proficiency in CMMS platforms such as D365 EAM SAP PM Maximo or equivalent systems to manage calibration schedules documentation and asset history.
Collaborate effectively with internal stakeholders and service partners to deliver high-quality customer-focused calibration and maintenance solutions.
Communicate clearly and professionally both verbally and in writing to ensure accurate documentation and effective coordination across teams.
Apply strong organizational skills and attention to detail to maintain data integrity ensure compliance and achieve audit readiness.
Demonstrated ability to develop coordinate and execute planned shutdowns ensuring adherence to timelines safety protocols and operational requirements.
Non-Technical Skills
Results-oriented and able to navigate ambiguity.
Set clear outcomes track progress follow through on commitments and ensure 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.
Must be able to work in a regulated manufacturing environment including construction/start-up phases with appropriate PPE. Reasonable accommodation will be provided as required by law.
This position is based on-site in Sanford NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
Requires up to 5% domestic travel based on business needs.
During construction and commissioning phases the position follows a MondayFriday day shift. During production runs the schedule transitions to a 2-2-3 day shift as needed (12-hour day shift (7a.m.7 p.m.) following a 2-2-3 rotation (two days on two days off three days on alternating weekly)). Schedule provides every other weekend off
This position is designated as essential to site operations as such the employee may be required to report to the facility or remain on-site during certain operational or emergency situations to ensure business continuity.
On-call availability may be required to support urgent operational needs.
Must be able to perform the physical requirements of the role including occasionally lifting to 50 lbs with or without reasonable accommodation.
Regularly works in environments with exposure to machinery noise and physical hazards. Appropriate personal protective equipment (PPE) is required at all times.
The anticipated salary for this position will be $35 to $48 per/hour. 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:
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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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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The Kyowa Kirin Group is a Japanese pharma group that develops innovative specialty drugs, to raise the health and well-being of people around the world. Its flagship business Kyowa Kirin Co., Ltd. creates antibody-based drugs for cancer, kidney disease, and immune system diseases.