Summary:The Sr. Maintenance Specialist will support our facilities and maintenance operations in a GMP-regulated life sciences environment. The ideal candidate will be responsible for managing the CMMS, EDMS, maintenance spare parts, deviations, change controls, CAPAs and other duties as assigned, to ensure compliance, data integrity, and efficient scheduling and tracking of maintenance activities for critical equipment and infrastructure.
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 organization's 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.
Essential Functions:Technical Skills
• Administer and maintain the Computerized Maintenance Management System (CMMS) to support preventive, corrective, and predictive maintenance programs.
• Administer and maintain the Engineering Document Management System (EDMS) to support our control and custody of all documents related to the building and equipment.
• Develop, update, and manage asset records, PM schedules, work orders, and maintenance history in the CMMS.
• Work with IT and CMMS/EDMS vendors to troubleshoot technical issues and implement improvements.
• Generate periodic reports and KPIs related to maintenance performance, equipment reliability, and compliance.
• Schedule calibrations, maintenance, and vendor PMs
• Maintain data integrity with new assets, moves, and retirements.
• Control and manage spare part inventory utilizing the CMMS and our ERP system (D365).
Administrative
• Provide software training to end users and new administrators and serve as a liaison for problem-solving and escalation
• Lead or participate in system upgrades, validation, and configuration changes, ensuring compliance with 21 CFR Part 11 and other relevant regulations.
• Author and support deviations, change controls and CAPA's for the maintenance department.
• Represent the maintenance department in critical investigations as required.
• Support regulatory audits by providing documentation, maintenance history reports, and CMMS/EDMS data as needed.
Requirements:Education
High School diploma or equivalent required. Associate or bachelor's degree preferred.
Experience
5-7 years' experience working within a CMMS environment preference given to those with SAP or Microsoft Dynamic experience.
5-7 years relevant experience with a CMMS, EDMS, authoring and supporting deviations, and change controls.
Experience managing spare parts
Technical Skills
Experience with CMMS platforms, such as D365 EAM, SAP PM, Maximo or other CMMS platforms preferred. Experience with an EDMS (preferably Adept). Experience authoring and participating in investigations and associated corrective actions. Ability to work collaboratively with our clients to promote excellence in customer service. Ability to import data, create templates and export data as required is a plus. Ability to generate reports and modify reports as needed. Strong communication and organizational skills. Excellent attention to detail and data integrity.
Physical Demands:Initially working on a construction site and ultimately in a biotech
manufacturing site in Sanford, NC. Work is 100% on-site. This is not a hybrid or remote role.
Working Conditions:May require up to 5% of domestic travel. Long periods of standing and sitting required. Exposure to machinery, noise, and physical hazards (with proper PPE).
The anticipated salary for this position will be
$41.78/hr to $44.00/hr. 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:
- 401K with company matching
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Long-Term Incentive Program (subject to job level and performance)
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
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
