Maintenance Planner

Role Summary

We are seeking a highly organized and detail-oriented Maintenance & Calibration Planner with proven experience in the pharmaceutical and medical device industry. This role is responsible for planning, scheduling, and optimizing both maintenance and calibration activities to ensure equipment reliability, regulatory compliance, and operational efficiency. A strong background in Computerized Maintenance Management Systems (CMMS)—particularly Blue Mountain RAM (BMRAM)—is essential. This position is primarily on-site at the Bedford, MA facility, with some flexibility for hybrid work depending on project needs and team coordination.

Responsibilities

• Develop and manage preventive and corrective maintenance schedules for GMP-critical and non-GMP assets.
• Plan and coordinate calibration activities for instruments, sensors, and control systems in accordance with regulatory and internal standards.
• Administer and maintain CMMS (preferably BMRAM), ensuring accurate asset data, calibration intervals, work order tracking, and documentation.
• Ensure calibration records are complete, traceable, and compliant with FDA, ISO, and other applicable regulatory standards.
• Collaborate with Quality, Manufacturing, and Engineering teams to align maintenance and calibration activities with production schedules and compliance requirements.
• Generate and analyze metrics (e.g., PM and calibration completion rates, equipment downtime, backlog) to drive continuous improvement.
• Support validation and qualification efforts for equipment and utilities, including calibration-related documentation.
• Maintain spare parts and calibration standards inventory; coordinate procurement to replenish consumed inventory and maintain appropriate safety stock levels.
• Lead planning for shutdowns, calibrations, and major equipment overhauls.
• Train technicians and users on CMMS workflows, calibration procedures, and best practices.

Qualifications

• Required: Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
• Required: 5+ years of maintenance and calibration planning experience in a regulated pharma or medical device environment.
• Required: Hands-on experience with CMMS platforms; Blue Mountain RAM (BMRAM) strongly preferred.
• Required: Familiarity with GMP, FDA 21 CFR Part 11, ISO 13485, and other regulatory frameworks.
• Required: Strong analytical, organizational, and communication skills.
• Required: Proficiency in Microsoft Office Suite and data visualization tools.
• Preferred: Experience supporting audits and inspections (FDA, ISO, internal).
• Preferred: Knowledge of equipment qualification, calibration protocols, and validation lifecycle.
• Preferred: Lean or Six Sigma certification is a plus.
• Preferred: Ability to read and interpret engineering drawings, calibration certificates, and technical manuals.