Metrology & Maintenance Engineer

Role Summary

The Metrology & Maintenance Engineer is responsible for executing asset lifecycle maintenance activities. This includes requalification, calibration, maintenance, and repairs within their technical area of expertise. The goal is to ensure that all technical solutions are both reliable and cost-effective while meeting GMP regulatory requirements.

Responsibilities

• Plan, schedule, and oversee preventive and corrective maintenance activities to ensure equipment and utilities function reliably and efficiently.
• Lead calibration activities for all critical instruments, ensuring traceability, accuracy, and compliance with industry standards.
• Ensure all maintenance and calibration activities are documented and executed per GMP requirements.
• Oversee the execution of work orders, ensuring timely completion and quality outcomes.
• Supervise technicians and contractors, providing guidance and ensuring adherence to SOPs and safety protocols.
• Maintain up-to-date and accurate documentation in the Computerized Maintenance Management System (CMMS).
• Develop and execute preventive and corrective maintenance plans, prioritizing according to risk and criticality.
• Participate in reliability reviews and root cause failure analyses to drive continuous improvement.
• Supervise operational readiness activities for new or modified assets, ensuring seamless integration into production environments.
• Act as the subject matter expert (SME) for complex technical issues, driving root cause analysis and implementation of effective solutions.
• Lead or contribute to projects focused on equipment, utility, and facility improvements, ensuring alignment with operational goals and lifecycle cost management.
• Maintain rigorous adherence to GMP guidelines in all maintenance and calibration processes.
• Develop, implement, and monitor standard operating procedures (SOPs) to ensure regulatory compliance and best practices.
• Champion Health, Safety, and Environmental (HSE) programs, ensuring all maintenance and calibration activities comply with safety and environmental standards.
• Prepare for and participate in regulatory and quality audits, addressing findings and implementing corrective actions as needed.
• Coach, mentor, and motivate team members, fostering a collaborative and high-performance work environment.

Qualifications

• 10+ years' experience in Pharmaceutical Industry (Cell & Gene Therapy Aseptic Processing); Facility and GMP Lab equipment experience preferred
• Functional breadth GMP Facility asset lifecycle requirements
• Collaborating across boundaries
• Lab Equipment PM & Calibration Operations Management and Execution