Maintenance & Calibration Scheduler / Planner

Alcami Corporation•Morrisville, NC
•Onsite

About The Position

The Maintenance & Calibration Scheduler / Planner plans, schedules, and coordinates preventive, predictive, and corrective maintenance and instrument calibration in a fast-paced FDA-regulated environment. The role ensures work is appropriately planned, labor and materials are available, equipment meets calibration requirements, and management has accurate data for decision-making. It works closely with maintenance and calibration technicians, Operations, Production, Quality, Purchasing, equipment owners, engineers, and vendors, applying independent judgment and considering safety, regulatory, operational, and business impacts. This is a 100% on-site position in Morrisville, North Carolina, on first shift, Monday through Friday, 7:00 a.m. to 4:00 p.m. Travel of up to 5% is required. The position manages maintenance planning and scheduling, calibration records and vendor coordination, purchasing and quotes, MRO inventory, reporting and KPIs, and continuous improvement and compliance. It maintains accurate CMMS/ERP data and documentation, supports audits and impact assessments, troubleshoots equipment with relevant stakeholders, and ensures work is documented and completed in accordance with cGMP, safety, quality, and other applicable requirements. The role also maintains an organized workspace, completes required training, and performs other duties as assigned. The work involves a mix of office and industrial/facilities environments. The employee may encounter moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, wet or humid conditions, elevated or precarious locations, electrical-shock risk, vibration, and moderate noise. Appropriate personal protective equipment is required for specific duties; some elevated work may require a body harness and lanyard, and the employee may be required to operate an industrial vehicle. Physical duties include standing, handling and reaching, walking, climbing or balancing, stooping, kneeling, crouching or crawling, and lifting items of varying weights, sometimes over 100 pounds with assistance.

Requirements

  • High school diploma or equivalent with at least 6 years of experience in a regulated environment (such as FDA or NRC) performing repairs on production and/or utility equipment; alternatively, an associate or bachelor's degree with at least 3 years of experience in maintenance planning/scheduling, calibration coordination, or a related industrial role.
  • Prior pharmaceutical cGMP experience required.
  • Experience obtaining vendor quotes and creating purchase requisitions.
  • Strong proficiency in Microsoft Excel, including pivot tables, formulas, and charts, and working knowledge of Microsoft Office applications.
  • Excellent organizational, time-management, and multitasking skills.
  • Strong written and verbal communication skills; excellent verbal communication and presentation skills required.
  • Attention to detail and data accuracy.
  • Problem-solving ability and sound prioritization.
  • Ability to collaborate with vendors and across departments, and to work with technicians, supervisors, and management.
  • Ability to work with changing priorities and deadlines.
  • Analytical and reporting skills.
  • Excellent knowledge of cGMP in a pharmaceutical or regulated environment required.
  • Strong understanding of Standard Operating Procedures required.
  • Working knowledge of Microsoft Office (Word, Excel, and PowerPoint) required.
  • Ability to meet the stated physical demands, with reasonable accommodation where applicable, and use required personal protective equipment.

Nice To Haves

  • Mechanical, electrical, or instrumentation background.
  • Familiarity with calibration standards and quality systems, including ISO 9001, ISO/IEC 17025, and GMP.
  • Experience with inventory/storeroom management and MRO parts.
  • Certified Maintenance & Reliability Professional (CMRP), Certified Planner, or similar certification.
  • Experience with Power BI or other reporting tools.
  • Strong knowledge of general OSHA safety requirements.
  • Working knowledge of CMMS software for scheduling and documenting work, including systems such as SAP PM, Maximo, Fiix, UpKeep, or eMaint.
  • Working knowledge of JCI Metasys Building Management System.

Responsibilities

  • Develop and maintain CMMS schedules for preventive, predictive, and corrective maintenance work orders.
  • Plan jobs in advance, including scope, labor hours, required skills, tools, parts, permits, and safety requirements.
  • Coordinate downtime windows with Operations and Production; prioritize and sequence work based on criticality, safety, regulatory requirements, and resource availability.
  • Create, review, and close work orders, documenting labor, parts, findings, and required GMP information accurately and on time.
  • Monitor schedule compliance and work-order backlog, adjusting plans as priorities change.
  • Maintain the master calibration schedule and equipment/instrument register; track due dates and notify technicians and equipment owners to prevent overdue or out-of-tolerance instruments.
  • Coordinate in-house calibrations and external calibration vendors, including shipment and tracking of equipment sent offsite.
  • Maintain calibration records, certificates, and traceability documentation, and support audits by providing accurate maintenance and calibration records.
  • Flag out-of-tolerance calibration findings and coordinate impact assessments with Quality.
  • Request, obtain, and compare vendor quotes; prepare purchase requisitions with approvals, cost coding, and justification.
  • Follow up on vendor orders, lead times, and deliveries; expedite critical items, work with Purchasing on pricing and vendor relationships, and resolve order discrepancies.
  • Verify receipt of parts and services against purchase orders, support invoice reconciliation, track maintenance spending, and identify cost-saving opportunities.
  • Maintain MRO inventory records in the CMMS/ERP; establish and review min/max levels, reorder points, and critical spares lists.
  • Perform cycle counts and reconcile inventory discrepancies; ensure parts are received, labeled, stored, and issued correctly.
  • Identify obsolete, excess, or slow-moving inventory and recommend actions; kit materials for planned jobs.
  • Create and distribute reports on PM compliance, schedule adherence, backlog, calibration status and overdue items, downtime, maintenance costs, and inventory.
  • Track KPIs such as planned versus unplanned work, MTBF, and MTTR; analyze trends and recommend improvements to PM strategies and intervals.
  • Prepare management summaries and presentations as requested.
  • Keep CMMS asset records, PM tasks, bills of materials, and procedures accurate and up to date; support improvements to planning and scheduling procedures.
  • Follow safety, quality, regulatory, cGMP, and training requirements; participate in audits, safety meetings, and continuous improvement initiatives.
  • Keep Maintenance Management routinely informed of developments.
  • Troubleshoot equipment with equipment owners, engineers, and vendors and participate in developing solutions to equipment issues.
  • Develop and encourage effective working relationships among Facilities staff and internal and external customer departments.
  • Maintain an organized and clean workspace and perform other duties as assigned.
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