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 skills are required.

§ Computer Literacy…