Maintenance Supervisor

The Maintenance Supervisor – 24/7 Operations is responsible for leading shift-based maintenance execution in a GMP-regulated biologics manufacturing facility supporting Bulk, Fractionation, and Fill & Finish operations. This role ensures safe, compliant, and reliable operation of critical manufacturing and utility systems across continuous operations. The supervisor provides real-time technical leadership, drives rapid troubleshooting response, and ensures disciplined execution of preventive and corrective maintenance activities to minimize production downtime while maintaining inspection readiness.

Leadership & Supervision§  Lead and coordinate maintenance technicians during assigned shift.§  Serve as first-line escalation for production-critical breakdowns.§  Drive immediate troubleshooting of equipment impacting:

Bulk (chromatography skids, TFF/UF systems, etc.)Fractionation (centrifuges, cold ethanol systems, filter press, etc.)Fill & Finish (isolators, vial fillers, cappers, lyophilizers, inspection)§  Prioritize emergency vs. planned work to protect batch integrity.§  Ensure structured shift handoff between supervisors and technicians (written + verbal)
Maintenance Execution & Reliability§  Manage and supervise a comprehensive range of maintenance activities, including preventive, predictive, and corrective measures. Ensure that all work orders are processed and closed promptly within the CMMS (SAP Maintenance).§  Provide support in diagnosing and resolving complex equipment failures, facilitating effective troubleshooting to achieve optimal performance and minimizing downtime.§  Reduce periods of inactivity by conducting root cause analyses and implementing appropriate corrective measures.

§  Enhance operational reliability by actively supporting initiatives focused on improving system dependability and efficiently managing the entire lifecycle of assets.

GMP & Regulatory Compliance (Shift Accountability)§  Ensure all maintenance work is properly documented in CMMS (SAP).§  Verify work order accuracy and documentation completeness.§  Initiate emergency change controls when required.§  Ensure audit-ready condition at all times.§  Support FDA/EMA inspections, including off-shift auditor support if required.

Workforce Planning & Development§  Assign technicians based on skill matrix and equipment criticality.§  Train and develop multi-skilled maintenance technicians.§  Identify skill gaps and recommend training plans.§  Reinforce accountability and performance standards.§  Conduct performance feedback discussions.

Planning & Continuous Improvement§  Partner and collaborate with the Maintenance Planner to continuously improve preventive maintenance (PM) scheduling, enhancing asset reliability, planning efficiency, and schedule adherence Improve spare parts management and critical spares strategy.§  Drive 5S and maintenance excellence practices.§  Support Lean / TPM / Reliability Centered Maintenance initiatives.§  Identify opportunities for cost savings and process improvements.

Shift Structure & Coverage Model§  This role operates within a 24/7 manufacturing environment, which may include:12-hour rotating shifts (2-2-3 model)
Fixed day or night shift coverage

Weekend production support

On-call escalation coverage

Holiday coverage as required§  Each shift supervisor has full ownership of maintenance execution during their assigned shift and serves as the primary engineering escalation point for Manufacturing.

Completes any other duties/responsibilities assigned by senior management Education §  Associate or bachelor’s degree in engineering, Industrial Maintenance, or related technical field preferred

Experience§  7+ years in biotech/pharma maintenance§  3+ years in a supervisory or shift-lead role§  Strong experience in GMP-regulated biologics manufacturing§  Experience supporting at least two of the following:§  Bulk biologics production§  Plasma fractionation§  Aseptic fill & finish§  Proficient knowledge of Good Manufacturing Practices (GMPs)§  Audit and Investigation Skills, Report Writing Skills.§  Ability to develop cohesive presentations§  Strong verbal, technical writing, and interpersonal…