Maintenance & Calibration Scheduler / Planner

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Maintenance & Calibration Scheduler / Planner  is accountable for driving results in a fast-paced FDA environment. The Maintenance & Calibration Scheduler / Planner is responsible for planning, scheduling, and coordinating all preventive maintenance, corrective maintenance, and instrument calibration activities. This role ensures work is properly planned, parts and services are available when needed, equipment stays in compliance with calibration requirements, and management has accurate data to support decisions. The position works closely with maintenance technicians, calibration technicians, operations, quality, and purchasing. The Maintenance & Calibration Scheduler / Planner applies critical thinking and considers all business impact aspects before taking job related actions that could cause unwanted consequences such as loss of revenue, unsafe events, and other risks. The Maintenance & Calibration Scheduler/ Planner is able to apply independent judgment and perform in a small company environment, where rapid changes occur constantly.

On-Site Expectations

• 100% on-site position in Morrisville, NC.
• 1st Shift: Monday - Friday, 7:00am - 4:00pm.

Responsibilities

Maintenance Planning & Scheduling

• Develop and maintain schedules for preventive maintenance (PM), predictive maintenance, and corrective work orders in the CMMS.
• Plan jobs in advance, including scope, labor hours, required skills, tools, parts, permits, and safety requirements.
• Coordinate downtime windows with Operations and Production to minimize disruption.
• Prioritize and sequence work based on criticality, safety, regulatory requirements, and resource availability.
• Create, review, and close out work orders; ensure accurate documentation of labor, parts, and findings.
• Monitor schedule compliance and backlog, and adjust plans as priorities change.

Calibration Management

• Maintain the master calibration schedule and equipment/instrument register.
• Track calibration due dates and notify technicians and equipment owners in advance to prevent overdue or out-of-tolerance instruments.
• Coordinate in-house calibrations and schedule external calibration vendors, including shipping and tracking of equipment sent offsite.
• Maintain calibration records, certificates, and traceability documentation in compliance with applicable standards (e.g., ISO 9001, ISO/IEC 17025, FDA, or customer requirements).
• Support audits by providing accurate calibration and maintenance records.
• Flag out-of-tolerance findings and coordinate impact assessments with Quality.

Quotes & Purchasing

• Request, obtain, and compare quotes from vendors for parts, services, contractors, and calibration providers.
• Prepare and submit purchase requisitions/requests with proper approvals, cost coding, and justification.
• Follow up with vendors on order status, lead times, and delivery; expedite critical items as needed.
• Work with Purchasing to negotiate pricing, develop preferred vendor relationships, and resolve order discrepancies.
• Verify receipt of parts and services against purchase orders and support invoice reconciliation.
• Track maintenance spend against budget and identify cost-saving opportunities.

Parts & Inventory Management

• Maintain accurate MRO (maintenance, repair, and operations) parts inventory records in the CMMS/ERP.
• Establish and review min/max levels, reorder points, and critical spares lists.
• Perform regular cycle counts and reconcile discrepancies.
• Ensure parts are properly received, labeled, stored, and issued to work orders.
• Identify obsolete, excess, or slow-moving inventory and recommend actions.
• Kit parts and materials for planned jobs ahead of scheduled work.

Reporting & Analysis

• Create and distribute regular reports, including PM compliance, schedule adherence, work order backlog, calibration status and overdue items, downtime, and maintenance costs.
• Report on inventory levels, usage trends, stockouts, and inventory accuracy.
• Track and report key performance indicators (KPIs) such as planned vs. unplanned work, mean time between failures (MTBF), and mean time to repair (MTTR).
• Analyze data to identify recurring issues and recommend improvements to PM strategies and intervals.
• Prepare summaries and presentations for management as requested.

Continuous Improvement & Compliance

• Keep CMMS data (asset records, PM tasks, BOMs, procedures) clean, accurate, and up to date.
• Support development and improvement of planning and scheduling procedures.
• Follow all safety, quality, and regulatory requirements.
• Participate in audits, safety meetings, and continuous improvement initiatives.
• Ensures Maintenance Management informed of all developments on a routine basis.
• Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors. Involved in developing solutions for equipment issues.
• Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner. Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
• Maintains an organized and clean workspace at all times.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• High School Diploma or equivalent with 6+ years of experience working in a regulated environment (FDA, NRC or similar performing repairs on production and/or utility equipment. Associate’s degree or Bachelor's degree with 3+ years of experience in maintenance planning/scheduling, calibration coordination, or a related industrial role.
• Prior pharma cGMP experience required.

Knowledge, Skills, and Abilities

• Working knowledge of CMMS software (e.g., SAP PM, Maximo, Fiix, UpKeep, eMaint) and ERP/purchasing systems.
• Experience obtaining quotes and creating purchase requisitions.
• Strong proficiency in Microsoft Excel (pivot tables, formulas, charts) and other Office applications.
• Excellent organizational, time management, and multitasking skills.
• Strong written and verbal communication skills.

• Preferred

  • Mechanical, electrical, or instrumentation background.
  • Familiarity with calibration standards and quality systems (ISO 9001, ISO/IEC 17025, GMP, etc.).
  • 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.
• Attention to detail and data accuracy.
• Problem solving and sound prioritization.
• Vendor and cross-department collaboration.
• Ability to work with technicians, supervisors, and management.
• Comfort working under changing priorities and deadlines.
• Analytical and reporting skills.
• Excellent knowledge of cGMP in a pharmaceutical or regulated environment required.
• Excellent verbal communications and presentation skills required.
• Strong knowledge of general OSHA safety requirements preferred.
• Strong understanding of Standard Operating Procedures required.
• Working knowledge of Microsoft Office (Word, Excel, PowerPoint) required.
• Working knowledge of Computerized Maintenance Management Systems to schedule and document work performed preferred.
• Working knowledge of JCI Metasys Building Management System preferred.

Travel Expectations

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 80 pounds and occasionally lift and/or move over 100 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.