Manager, Maintenance & Calibration Operations

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +1

The Manager, Maintenance & Calibration Operations leads maintenance and calibration activities within the manufacturing team, ensuring all equipment and instruments meet regulatory standards, quality requirements, and operational efficiency. This role involves developing and implementing calibration and maintenance procedures, managing a team, and driving continuous improvement initiatives to optimize equipment reliability and compliance across manufacturing, and QC operations. The Manager applies extensive knowledge of maintenance and calibration processes, industry standards, and regulatory guidelines to establish, streamline workflows, and minimize equipment downtime. Additionally, this role involves analyzing trend data, coordinating with cross-functional teams, and ensuring adherence to safety, quality, and environmental standards to support manufacturing excellence.

What you'd actually do

  1. Develops and communicates calibration strategies, policies, and procedures aligned with industry standards (e.g., ISO, ASTM, FDA) and organizational goals.
  2. Leads planning and execution of calibration schedules, ensuring timely and accurate calibration of all equipment and instruments.
  3. Implements best practices for calibration, preventive maintenance, and equipment validation to support manufacturing excellence.
  4. Supervises calibration technicians and maintenance personnel, providing coaching, training, and performance evaluations.
  5. Promotes a culture of safety, quality, and continuous improvement within the calibration and maintenance team.

Skills

Required

  • Bachelor’s degree in Engineering, Manufacturing, or a related field
  • Minimum 6 years of experience in calibration, maintenance, or manufacturing operations
  • Minimum 3 years of leadership experience within regulated industries
  • Strong knowledge of regulatory standards (FDA, ISO, Anvisa, EMA) and quality systems
  • Experience supporting audits and maintaining audit-ready documentation
  • Deep understanding of calibration principles, measurement systems, and maintenance practices
  • Familiarity with calibration management systems and data analysis tools
  • Proven leadership skills with the ability to motivate and develop teams
  • Strong analytical, troubleshooting, and decision-making capabilities
  • Excellent communication skills, both written and verbal

Nice to have

  • advanced certifications in calibration or maintenance
  • biopharma or cell therapy experience

What the JD emphasized

  • regulatory standards
  • quality requirements
  • operational efficiency
  • equipment reliability
  • compliance
  • regulatory guidelines
  • safety
  • quality
  • environmental standards
  • regulatory standards (FDA, ISO, Anvisa, EMA)
  • quality systems
  • audits
  • audit-ready documentation