Maintenance & Calibration Scheduler / Planner
Alcami Corporation
Summary
The Maintenance & Calibration Scheduler / Planner is accountable for driving results in a fast-paced FDA environment. This role is responsible for planning, scheduling, and coordinating all preventive maintenance, corrective maintenance, and instrument calibration activities. The position works closely with maintenance technicians, calibration technicians, operations, quality, and purchasing.
Job description
Job Summary
The Maintenance & Calibration Scheduler / Planner is accountable for driving results in a fast-paced FDA environment. This role is responsible for planning, scheduling, and coordinating all preventive maintenance, corrective maintenance, and instrument calibration activities. The position works closely with maintenance technicians, calibration technicians, operations, quality, and purchasing.
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 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.
- Troubleshoot equipment as necessary, working with equipment owners, engineers, and equipment vendors.
- Complete required paperwork and documentation, work orders and GMP documents in a clear, accurate and timely manner.
- Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments.
- Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
Requirements
- 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
- 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
- Excellent knowledge of cGMP in a pharmaceutical or regulated environment required
- Excellent verbal communications and presentation skills required
- Strong understanding of Standard Operating Procedures required
- Working knowledge of Microsoft Office (Word, Excel, PowerPoint) required
- Preferred: Mechanical, electrical, or instrumentation background
- Preferred: Familiarity with calibration standards and quality systems (ISO 9001, ISO/IEC 17025, GMP, etc.)
- Preferred: Experience with inventory/storeroom management and MRO parts
- Preferred: Certified Maintenance & Reliability Professional (CMRP), Certified Planner, or similar certification
- Preferred: Experience with Power BI or other reporting tools
- Preferred: Strong knowledge of general OSHA safety requirements
- Preferred: Working knowledge of Computerized Maintenance Management Systems to schedule and document work performed
- Preferred: Working knowledge of JCI Metasys Building Management System
Company overview
Alcami Corporation is a leading US-based contract development and manufacturing organization (CDMO) with over 45 years of experience in advancing pharmaceuticals and biologics from development to commercial delivery. Headquartered in North Carolina, the company operates six campuses strategically located near major pharmaceutical and biotech hubs across the United States. Alcami provides comprehensive, integrated solutions including analytical development and testing services, drug product manufacturing for both oral solid dose and sterile parenteral products, cGMP pharmaceutical storage, and support services such as environmental monitoring, calibration, and validation. With more than 1,000 employees and 770,000 square feet of operational space, Alcami serves pharmaceutical and biotechnology companies of all sizes, from virtual startups to large established organizations. The company's expertise spans small and large molecules, complex formulations, and DEA-scheduled drug products, offering end-to-end solutions that support clients through every stage of the development lifecycle.