Biotech Maintenance Lead – GMP/Utilities

Kyowa Kirin, Inc.- U.S.; Sanford (NC); On-site; USD 60,000 - 69,000; Full time

Benefits offered by this job

401K matching

Annual bonus program

PTO and holidays

Healthcare benefits

Life & disability insurance

Tuition assistance

Employee referrals

Job summary

Kyowa Kirin North America, Inc. seeks a Lead Maintenance and Utilities Technician in Sanford, NC to manage on-site maintenance and utility operations at a biopharmaceutical manufacturing site.

The role requires strong GMP knowledge, regulatory compliance, and hands-on work with bioprocessing equipment, with a focus on minimizing downtime and maintaining a compliant production environment.

Qualifications

• Minimum 6-8 years of relevant maintenance experience.
• Experience in GMP or other regulated environments.
• Proficiency with CMMS systems (Indysoft, SAP PM, Maximo).

Responsibilities

• Perform scheduled inspections and preventive maintenance on bioprocessing equipment (bioreactors, centrifuges, filtration units).
• Diagnose equipment malfunctions and execute timely, effective repairs.
• Assist with installation and startup of new equipment; integrate with control systems (PLC, SCADA, DCS).
• Coordinate maintenance with manufacturing and laboratory teams to minimize disruptions.
• Maintain records to support audits and ensure GMP and FDA compliance.
• Collaborate with process engineers, QA, and manufacturing staff to ensure seamless operations.

Skills

Maintenance

GMP knowledge

Regulatory compliance

CMMS

Indysoft

SAP PM

Maximo

Documentation

Collaboration

Communication

Education

High school diploma

Related degree

Tools

Bioprocess equipment knowledge

Job description

Kyowa Kirin North America, Inc. seeks a Lead Maintenance and Utilities Technician in Sanford, NC to manage on-site maintenance and utility operations at a biopharmaceutical manufacturing site.

The role requires strong GMP knowledge, regulatory compliance, and hands-on work with bioprocessing equipment, with a focus on minimizing downtime and maintaining a compliant production environment.