Manufacturing Maintenance & Calibration Lead

About the role

The Manufacturing Maintenance & Calibration Lead is responsible for overseeing maintenance and calibration activities within the manufacturing team, ensuring all equipment and instruments meet regulatory standards, quality requirements, and operational efficiency.

Responsibilities

• Develops and communicates calibration strategies, policies, and procedures aligned with industry standards (e.g., ISO, ASTM, FDA) and organizational goals.
• Led planning and execution of calibration schedules, ensuring timely and accurate calibration of all equipment and instruments.
• Implements best practices for calibration, preventive maintenance, and equipment validation to support manufacturing excellence.
• Supervises calibration technicians and maintenance personnel, providing coaching, training, and performance evaluations.
• Promotes a culture of safety, quality, and continuous improvement within the calibration and maintenance team.
• Ensures team compliance with regulatory requirements and internal standards.
• Fosters a team environment that encourages innovation, proactive problem-solving, and professional development.
• Oversees maintenance and calibration activities, troubleshooting, and root cause analysis to resolve issues promptly.
• Develops and monitors key performance indicators (KPIs) such as calibration accuracy, turnaround times, and compliance metrics.
• Collaborates with production, quality, and engineering teams to prioritize maintenance and calibration activities and minimize operational disruptions.
• Conducts trend analysis of calibration and maintenance data to identify areas for process improvement and risk mitigation.
• Presents performance metrics and improvement initiatives to senior management and cross-functional stakeholders.
• Leverages advanced analytics and digital tools to enhance predictive maintenance and process optimization.
• Participates in regulatory audits and inspections, supporting compliance efforts.

Qualifications

• Education: Minimum of a Bachelor’s degree in Engineering, engineering technology, or a related technical field is required. Advanced certifications in calibration or maintenance are a plus.
• Required Experience & Skills: Minimum 6 years of experience in calibration or maintenance, or manufacturing operations; biopharma or cell therapy experience is preferred. Minimum 3 years of leadership experience within regulated industries. Working knowledge of regulatory standards (FDA, ISO, Anvisa, EMA) and quality systems. Experience supporting audits and maintaining audit-ready documentation. Deep understanding of calibration principles 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 and decision-making capabilities. Excellent communication skills, both written and verbal, with the ability to convey technical information clearly. Skilled in managing multiple projects, prioritizing tasks, and managing schedules.
• Preferred Skills: Audit Management, Business Alignment, Developing Others, EHS Compliance, Equipment Maintenance, Inclusive Leadership, Leadership, Lean Supply Chain Management, Manufacturing Standards, Performance Measurement, Process Improvements, Project Engineering, Quality Control Testing, Quality Validation, Repair Management, Science, Technology, Engineering, and Math (STEM), Application, Standard Operating Procedure (SOP), Team Management.