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Kyowa Kirin, Inc.- U.S. · 2 months ago

Senior Maintenance and Utilities Technician

Sanford, NC

Full-time

Hybrid

Mid, Senior Level

$35/hr - $48/hr

3+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company headquartered in Princeton, NJ, focused on delivering novel medicines in various disease areas. The Senior Maintenance and Utilities Technician will ensure the reliable operation and maintenance of facility utilities and equipment, manage complex projects, and mentor other technicians while adhering to GMP and regulatory compliance.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

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

Qualification

CGMP maintenanceBioprocessing equipmentCMMS platformsTechnical troubleshootingGxP environmentPreventive maintenanceSafety protocolsInterpersonal skillsOrganizational skillsCommunication skillsProblem-solving

Required

High school diploma or equivalent, with a minimum demonstrated 3–5 years of relevant cGMP maintenance experience

Minimum demonstrated 3–5 years of hands-on experience performing cGMP mechanical maintenance in both process and laboratory environments

Minimum demonstrated 2–4 years of experience working within a GxP or other highly regulated environment

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