Maintenance Engineer

The Maintenance Engineer (Equipment Engineer) provides technical oversight for Cell Therapy and Viral Vector manufacturing equipment across its full lifecycle. This role partners closely with Manufacturing, Quality Control, Validation, and Quality teams to support day-to-day operations, equipment qualification, preventive maintenance, troubleshooting, and continuous improvement within a GMP-regulated environment.

The position supports critical equipment such as incubators, biological safety cabinets, automated cell processing systems, and other advanced cell therapy manufacturing platforms.

Key Responsibilities

• Provide technical ownership and lifecycle management of GMP equipment used in Cell Therapy and Viral Vector manufacturing.
• Establish, maintain, and continuously improve preventive and predictive maintenance programs to maximize equipment uptime and reliability.
• Troubleshoot equipment issues, perform root cause analysis, and implement corrective and preventive actions.
• Coordinate and oversee external service providers to ensure timely, compliant maintenance and repairs.
• Document maintenance activities and promptly update the CMMS upon task completion.
• Author, review, and execute IQ/OQ/PQ protocols in compliance with GMP and regulatory requirements (e.g., FDA, ICH).
• Partner with Quality, Validation, and Manufacturing teams to ensure equipment qualification documentation is accurate, complete, and audit-ready.
• Manage equipment change controls and provide technical assessments for deviations and CAPAs, ensuring adherence to timelines.
• Train manufacturing and laboratory personnel on proper equipment operation and maintenance procedures as needed.
• Ensure maintenance activities and equipment changes do not negatively impact the validated state of equipment.
• Lead or support technology transfer of new equipment and unit operations into development and manufacturing environments.
• Support development of User Requirements Specifications (URS), design reviews, and qualification documentation to ensure fitness for intended use.
• Provide guidance on test plans, verification packages, and return-to-service requirements following maintenance or interventions.
• Support internal and external audits by providing technical expertise and documentation.
• Collaborate cross-functionally with Equipment Development, Manufacturing, Quality Control, Quality Assurance, IT, and other departments.
• Track and report key performance indicators aligned with manufacturing and operational goals.
• Identify opportunities to optimize equipment performance, reduce costs, and improve reliability through best practices and innovation.
• Perform routine maintenance activities as required.
• Complete additional duties as assigned.

Qualifications & Skills

• Bachelor’s degree in Engineering or related field.
• 7+ years of relevant experience, preferably within the biotech or life sciences industry, or an equivalent combination of education and experience.
• 4+ years of experience working in a regulated (GMP) manufacturing environment.
• Experience supporting equipment in cell therapy manufacturing, including closed-system platforms for T-cell or similar therapies.
• Strong knowledge of equipment qualification, validation, and lifecycle management.
• Experience supporting audits (internal and external) preferred.
• Strong documentation skills with meticulous attention to detail and adherence to SOPs.