GMP Maintenance Specialist – CMMS & EDMS Lead

Kyowa Kirin; Sanford (NC); On-site; USD 34,000 - 48,000; Full time

Benefits offered by this job

401K with company matching

Annual Bonus Program

Healthcare Benefits

Well-Being and Work/Life Programs

Long-Term Incentive Program

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Kyowa Kirin is seeking a Maintenance Specialist to support facilities and maintenance operations in a GMP-regulated environment at the Sanford, NC site. You will manage CMMS and EDMS, ensure data integrity, and assist with maintenance scheduling and record-keeping for critical equipment and infrastructure.

You will collaborate with IT and vendors, generate maintenance reports, and maintain compliance with 21 CFR Part 11.

Qualifications

• Must have experience with CMMS environments and data integrity.
• Experience with 21 CFR Part 11 compliance is preferred.
• Experience with creating and maintaining maintenance docs and reports.
• Ability to work collaboratively with clients and teams.

Responsibilities

• Administer and maintain CMMS for preventive, corrective, and predictive maintenance.
• Maintain EDMS for documents related to building and equipment.
• Develop asset records, PM schedules, work orders, and maintenance history.
• Generate reports and KPIs on maintenance performance and reliability.

Skills

Communication skills

Organizational skills

Teamwork

Problem solving

Attention to detail

Interpersonal skills

Education

High School diploma

Associate or Bachelor's degree preferred

Tools

CMMS

EDMS

SAP PM

Maximo

D365 EAM

Job description

Kyowa Kirin is seeking a Maintenance Specialist to support facilities and maintenance operations in a GMP-regulated environment at the Sanford, NC site. You will manage CMMS and EDMS, ensure data integrity, and assist with maintenance scheduling and record-keeping for critical equipment and infrastructure.

You will collaborate with IT and vendors, generate maintenance reports, and maintain compliance with 21 CFR Part 11.