Manager, Maintenance & Calibration Operations

Manager, Maintenance & Calibration Operations

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.

Key Responsibilities

• Develops and communicates calibration strategies, policies, and procedures aligned with industry standards (e.g., ISO, ASTM, FDA) and organizational goals.
• Leads 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.
• Coordinates 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.
• Upholds Johnson & Johnson's Credo and Leadership Imperatives in daily interactions, exemplifying the company's core values.

Qualifications:

Education:

• Bachelor's degree in Engineering, Manufacturing, or a related field is required; advanced certifications in calibration or maintenance are a plus

Experience &

Skills:

Required:

• Minimum 6 years of experience in calibration, maintenance, or manufacturing operations; biopharma or cell therapy experience is preferred
• 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, with the ability to convey technical information clearly
• Skilled in managing multiple projects, prioritizing tasks, and managing schedules

Preferred:

• Project management skills, emphasizing safety, quality, and operational efficiency
• Operation Excellence Certification (Green Belt, Black Belt, or Problem Solving)

Other:

• May require standing, walking, and manual handling for extended periods
• Occasional lifting of equipment or tools up to a specified weight
• Adherence to safety protocols and use of PPE as required
• May require up to 10% domestic and/or international travel

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation…