Manager of Regulated Equipment Piedmont)

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Position Overview

(On-site position in Piedmont, SC)

The Manager of Regulated Equipment is responsible for the enterprise-wide management, maintenance, calibration, validation, and regulatory compliance of all regulated equipment and temperature monitoring systems utilized in the collection, processing, storage, testing, transportation, and distribution of blood and blood products. This position ensures all regulated equipment operates in compliance with FDA Current Good Manufacturing Practices (cGMP), AABB standards, internal quality requirements, and all applicable federal and state regulations.

This role provides strategic and operational leadership for the organization's metrology and regulated equipment programs, including preventive maintenance, calibration management, validation activities, temperature monitoring systems, documentation control, vendor coordination, and audit readiness. The Manager of Regulated Equipment oversees the Metrology Technician position and serves as the subject matter expert for regulated equipment compliance throughout the organization.

The Manager of Regulated Equipment supports compliance with FDA regulations including, but not limited to, 21 CFR Part 606, specifically §606.60 regarding equipment observation, standardization, calibration, maintenance, and documentation requirements for blood establishments.

Essential Functions

Regulatory Compliance and Quality Systems

• Oversees enterprise-wide compliance for all regulated equipment associated with blood collection, processing, testing, storage, transportation, and distribution
• Ensures compliance with FDA regulations, including 21 CFR Part 606, AABB standards, CLIA requirements, OSHA regulations, and applicable state regulations
• Develops, implements, and maintains policies, procedures, validation protocols, preventive maintenance schedules, calibration schedules, and associated documentation for regulated equipment systems
• Maintains inspection readiness for FDA, AABB, CLIA, state, and internal quality audits
• Coordinates responses and corrective actions related to equipment deficiencies, audit findings, deviations, CAPAs, and quality events
• Collaborates with Quality Assurance and Operational leadership to ensure equipment systems support regulatory compliance and product integrity
• Maintains documentation in accordance with cGMP requirements and document retention standards
• Ensures equipment records, maintenance logs, calibration reports, temperature records, validations, and certifications are complete, accurate, and audit ready

Equipment Management

• Oversees all regulated equipment used throughout the organization including, but not limited to:
  • Blood bank refrigerators and freezers
  • Plasma freezers and thawing equipment
  • Platelet incubators and agitators
  • Refrigerated and laboratory centrifuges
  • Temperature monitoring systems, Isensix® wireless monitoring sensors, gateways, and probes
  • Data loggers and continuous monitoring systems
  • Blood collection mixers and scales
  • Hemocues and laboratory testing equipment
  • Water baths and warming devices
  • Controlled room temperature monitoring systems
  • Transport coolers and shipping validation systems
  • Irradiators and sterilization equipment when applicable
  • Additional FDA-regulated or quality-critical equipment
• Oversees preventive maintenance, repairs, troubleshooting, calibration, standardization, and validation of regulated equipment
• Ensures all regulated equipment performs within validated operating parameters and manufacturer specifications
• Coordinates vendor services, third-party calibration providers, warranty repairs, and service agreements
• Evaluates and approves new regulated equipment, technologies, monitoring systems, and validation requirements
• Develops equipment lifecycle replacement plans and capital equipment recommendations
• Maintains enterprise equipment inventory and asset management systems for regulated equipment
• Oversees installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities as required
• Ensures temperature mapping and environmental qualification studies are completed and documented as required
• Reviews and approves calibration standards and traceability documentation to ensure NIST traceability where applicable

Temperature Monitoring Program

• Oversees enterprise temperature monitoring and alarm management systems for all regulated storage environments, including the Sensitech Isensix® continuous temperature monitoring platform and associated wireless sensor network infrastructure
• Manages installation, qualification, calibration, maintenance, validation, troubleshooting, and lifecycle management of Isensix temperature sensors, gateways, probes, monitoring software, alarm systems, and cloud-based monitoring platforms
• Ensures Isensix monitoring systems maintain continuous environmental monitoring compliance for blood products, reagents, laboratory environments, refrigerators, freezers, platelet incubators, transport containers, and controlled room temperature environments
• Oversees documentation, alarm response procedures, escalation protocols, user access management, and audit trail reviews associated with Isensix monitoring systems
• Oversees enterprise temperature monitoring and alarm management systems for all regulated storage environments
• Ensures continuous monitoring systems maintain compliance with blood product storage requirements
• Oversees calibration and certification of all temperature probes, monitoring devices, and recording systems
• Reviews temperature excursion investigations and assists with corrective and preventive actions
• Ensures appropriate backup systems, alarm notifications, and contingency procedures are maintained
• Assists with validation and qualification of transport containers and shipping systems

Leadership and Operational Support

• Supervises and develops Metrology Technician personnel responsible for metrology, calibration, preventive maintenance, regulated equipment support activities, and temperature monitoring systems
• Provides training and technical guidance to operational staff regarding proper use, monitoring, inspection, and documentation of regulated equipment
• Coordinates equipment support for fixed sites, mobile operations, laboratories, and blood distribution activities
• Collaborates with Facilities, Quality, Laboratory, Operations, Supply Chain, and Information Technology departments regarding regulated systems and equipment
• Assists with business continuity and emergency preparedness planning related to regulated equipment and storage systems
• Develops departmental operational and capital budgets related to regulated equipment management
• Monitors departmental expenses and recommends cost-effective equipment and service solutions
• Participates in after-hours response for critical equipment failures, temperature excursions, or emergency operational support when required

Other Duties

• Other duties as assigned. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Minimum Qualifications

• Bachelor's degree in Biomedical Engineering, Engineering Technology, Facilities Management, Life Sciences, Healthcare Technology Management, Industrial Technology, or related field preferred
• Minimum of five years of experience in regulated equipment maintenance, metrology, calibration management, biomedical equipment support, laboratory equipment management, blood banking, pharmaceutical manufacturing, healthcare engineering, or related field
• Supervisory or leadership experience preferred
• Experience working in FDA-regulated, cGMP, healthcare, laboratory, pharmaceutical, biologics, blood banking, or similar regulated environments preferred
• Knowledge of FDA regulations, AABB standards, calibration methodologies, equipment qualification, validation principles, and quality systems
• Understanding of temperature monitoring systems, environmental monitoring, and alarm management systems
• Knowledge of preventive maintenance systems, computerized maintenance management systems (CMMS), and asset management practices
• Ability to read and interpret technical manuals, specifications, engineering documents, calibration reports, and regulatory standards
• Knowledge of NIST traceability and metrology principles preferred
• Strong troubleshooting, analytical, organizational, and problem-solving skills
• Excellent written and verbal communication skills
• Ability to establish and maintain effective working relationships with staff, vendors, regulatory inspectors, and management
• Knowledge of Microsoft Office applications and computerized equipment management systems
• Valid Driver's License with no major infractions and dependable transportation
• Ability to travel between facilities and collection operations as needed

Physical Demands

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lifting and/or pulling/pushing up to 50 pounds occasionally
• Sitting, standing, or walking for extended periods of time
• Bending, twisting, kneeling, climbing, and crawling
• Ability to work around laboratory equipment, mechanical systems, and mobile operations environments
• Ability to respond to equipment emergencies and environmental alarms when required

Equal Opportunity Employer Veterans/Disabled