Abzena

Overview

Abzena is a dedicated partner in the development and manufacturing of biologics and bioconjugates, committed to quality excellence and efficient delivery of vital medicines. The Sr GMP Process Mechanic plays a critical role in the Facilities Maintenance team, ensuring the reliability and compliance of GMP manufacturing equipment and supporting utilities.

Responsibilities

• Perform planned preventative maintenance (PM) on GMP manufacturing equipment, laboratory equipment, and facility infrastructure.
• Perform corrective maintenance and emergency repairs to minimize equipment downtime.
• Troubleshoot mechanical, pneumatic, hydraulic, and process equipment failures.
• Maintain and repair manufacturing equipment including bioreactors, chromatography systems, and associated process equipment.
• Maintain facility equipment including HVAC systems, compressed air systems, and building utilities.
• Support maintenance activities within classified cleanrooms while following gowning procedures.
• Execute work orders using the Computerized Maintenance Management System (CMMS), ensuring complete and accurate documentation.
• Follow Good Documentation Practices (GDP) and cGMP requirements when documenting maintenance activities.
• Support equipment installation, commissioning, qualification, and validation activities.
• Assist Engineering with equipment modifications and continuous improvement initiatives.
• Participate in root cause investigations, deviations, CAPAs, and change controls as required.
• Support internal, client, and regulatory inspections by providing maintenance documentation and technical expertise.
• Maintain spare parts inventory and recommend critical spare requirements.
• Read and interpret mechanical drawings, piping and instrumentation diagrams (P&IDs), and technical documentation.
• Ensure all maintenance activities are performed safely and in accordance with OSHA and company safety requirements.
• Support shutdown activities, equipment relocations, facility projects, and capital improvement initiatives.
• Participate in the on-call rotation to support manufacturing and facility operations outside normal business hours.
• Identify opportunities to improve equipment reliability, maintainability, and overall operational performance.