Manager Maintenance and Calibration

Johnson & Johnson•Raritan, NJ

About The Position

We are searching for the best talent for a Manager Maintenance and Calibration to join our Team in Raritan, NJ. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. Summary: The Maintenance/Calibration Manager 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 of technicians, and driving continuous improvement initiatives to optimize equipment reliability and compliance across manufacturing 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.

Requirements

Bachelor’s degree in Engineering, Manufacturing, or a related field is required; advanced certifications in calibration or maintenance are a plus
Minimum 8 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
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 requires
May require up to 20% domestic and/or international travel

Nice To Haves

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

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.
Uphold Johnson & Johnson’s Credo and Leadership Imperatives in daily interactions, exemplifying the company’s core values.

Benefits

employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours