Maintenance Operations Lead - CGMP & 24/7 Support

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 95,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Maintenance Coordinator to drive daily maintenance activities, coordinate technician workflows, and ensure CGMP compliance across shifts in a 24/7 manufacturing environment.

You will partner with production, quality, and support teams to minimize downtime, manage parts and tools, and lead continuous improvement initiatives in a fast-paced biotech facility.

Qualifications

• Strong knowledge of maintenance workflows and equipment fundamentals.
• Excellent organizational and communication skills, both written and verbal.
• Demonstrated leadership skills with the ability to inspire and train others to drive team performance.
• Detail-oriented, dependable, and responsive in a fast-paced environment.
• Proficient with Microsoft Office, and maintenance systems view-only access.
• Knowledge of CGMP requirements, safety practices including LOTO and safe work permitting
• Familiar with Computerized Maintenance Management System (CMMS)
• Ability to develop effective working relationships internally and externally
• Problem-solving and Project Management skills
• Ability to effectively present information to others

Responsibilities

• Coordinates, prioritizes, and documents activities of technicians to support uninterrupted production while ensuring clear communication of completed work, delays or outstanding items, safety issues, and cross-departmental coordination for continuity across the site
• Identifies recurring issues by building and leads root cause analysis and continuous improvement initiatives
• Ensures the availability and procurement of materials, tools, spare parts, permits, and vendors for maintenance tasks and successful work order completion
• Ensures maintenance work complies with CGMP, safety, and documentation standards to promote consistent practices and standardization of maintenance practices across the site
• Participates in and provides data for audits and regulatory inspections as the technical subject matter expert (SME), as needed
• Leads or participates in planned responses (PRs), change management records (CMRs), and engineering change management (ECM)
• Attends daily tier meetings, and tracks equipment availability, status updates, and permit needs across buildings
• Supports equipment maintenance, calibration, qualification, and validation processes
• Assists with coordinating safety procedures such as Lockout Tagout (LOTO) and confined space entry
• Coordinates with supervisors to align technician dispatch, task prioritization, and onboarding of new personnel (contractors and employees) to the team
• Interfaces with production, quality, and other coordinators to synchronize work activities for continuity, workload balance, and equipment performance and reliability to ensure team achieves key performance indicators (KPIs)
• Develops, revises, and implements standard operating procedures (SOPs) and preventative maintenance plans to minimize equipment downtime
• Leads cross-functional team initiatives and decision-making processes while building and maintaining positive relationships with internal and external stakeholders
• Assists management with developing comprehensive maintenance workflows, scheduling training for team members, and providing mentorship to technicians
• Monitors projects and tasks to ensure adherence to codes, standards, timelines, and budget requirements while analyzing progress to coordinate timeline adjustments with stakeholders for optimal results
• Provides recommendations to management to develop and refine budget and schedule requirements
• Performs other duties, as assigned

Skills

Maintenance workflows

CGMP knowledge

CMMS

Leadership

Communication

Project management

Problem-solving

Safety (LOTO)

Documentation

Education

High school diploma/GED

Associate degree in engineering/biotechnology

Bachelor’s degree in engineering

Tools

CMMS

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Maintenance Coordinator to drive daily maintenance activities, coordinate technician workflows, and ensure CGMP compliance across shifts in a 24/7 manufacturing environment.

You will partner with production, quality, and support teams to minimize downtime, manage parts and tools, and lead continuous improvement initiatives in a fast-paced biotech facility.