GMP Facilities & CMMS 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 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.