Manager, Maintenance & Calibration Operations
About The Position
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.
Requirements
- 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
Nice To Haves
- Advanced certifications in calibration or maintenance are a plus
- 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
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Manager
