Maintenance Planner

What You’ll Do

• 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.

What It Takes

• Strong organizational, analytical, and coordination skills to effectively manage maintenance and calibration activities in a regulated manufacturing environment.
• Attention to detail, the ability to prioritize competing activities, and strong collaboration across Quality, Manufacturing, and Engineering teams.
• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
• 5+ years of maintenance and calibration planning experience in a regulated pharma or medical device environment.
• Hands-on experience with CMMS platforms; Blue Mountain RAM (BMRAM) strongly preferred.
• Familiarity with GMP, FDA 21 CFR Part 11, ISO 13485, and other regulatory frameworks.
• Strong analytical, organizational, and communication skills.
• Proficiency in Microsoft Office Suite and data visualization tools.
• Nice to Have:
• Experience supporting audits and inspections (FDA, ISO, internal).
• Knowledge of equipment qualification, calibration protocols, and validation lifecycle.
• Leverage of Lean or Six Sigma certification.
• Ability to read and interpret engineering drawings, calibration certificates, and technical manuals.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
• 5+ years of maintenance and calibration planning experience in a regulated pharma or medical device environment.
• Hands-on experience with CMMS platforms; Blue Mountain RAM (BMRAM) strongly preferred.
• Familiarity with GMP, FDA 21 CFR Part 11, ISO 13485, and other regulatory frameworks.

Skills

• Strong organizational, analytical, and coordination skills.
• Attention to detail, the ability to prioritize competing activities.
• Collaboration across Quality, Manufacturing, and Engineering teams.
• Proficiency in Microsoft Office Suite and data visualization tools.
• Hands-on experience with CMMS platforms; Blue Mountain RAM (BMRAM) strongly preferred.
• Familiarity with GMP, FDA 21 CFR Part 11, ISO 13485, and other regulatory frameworks.
• Strong analytical, organizational, and communication skills.
• Knowledge of equipment qualification, calibration protocols, and validation lifecycle.
• Leverage of Lean or Six Sigma certification.
• Ability to read and interpret engineering drawings, calibration certificates, and technical manuals.

Benefits

• Anika offers a discretionary bonus program for all full-time employees.
• Comprehensive healthcare benefits.
• Health savings account.
• 401(k) plan with up to 5% company match which includes immediate vesting.
• Employee stock purchase plan at a 15% discount.
• Accrued paid time off.
• Additional long-term incentives including stock awards.