Maintenance Engineering Supervisor

CSL Plasma; Kankakee (IL); Presencial; USD 97.000 - 115.000; Jornada completa

Descripción de la vacante

The Maintenance Supervisor - 24/7 Operations at CSL Plasma leads shift-based maintenance in a GMP-regulated biologics facility supporting Bulk, Fractionation, and Fill & Finish. You ensure safe, compliant operation and rapid troubleshooting to minimize downtime while keeping inspection readiness.

Reporting to the Head of Maintenance Services, you supervise technicians, drive preventive and corrective maintenance, and foster a culture of reliability, 5S, and continuous improvement across a 24/7

Formación

• 7+ years in biotech/pharma maintenance.
• 3+ years in a supervisory or shift-lead role.
• Strong GMP/regulatory knowledge for biologics manufacturing.
• Experience with Bulk biologics, Plasma fractionation, or aseptic fill & finish.
• Knowledge of FDA/cGMP standards and regulatory guidance.
• Excellent communication and problem-solving abilities.

Responsabilidades

• Lead and supervise maintenance technicians on assigned shift.
• Drive rapid troubleshooting of production-critical equipment.
• Ensure GMP-compliant maintenance documentation and SAP CMMS updates.
• Plan workforce and develop multi-skilled technicians.
• Drive continuous improvement, 5S, and reliability initiatives.
• Own shift-based maintenance execution in a 24/7 setting.

Conocimientos

Supervisory experience

GMP compliance

Root Cause Analysis

Communication skills

Asset management

Data-driven decision making

Educación

Associate's or Bachelor's degree in Engineering or related field

Herramientas

SAP

Trackwise

MS Office

Descripción del empleo

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.

Reporting Relationships: Role that this position reports to: Head of Maintenance Services. Role/s that report to this position: Maintenance Technicians.

Main Responsibilities and Accountabilities

• 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 (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 thorough 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 with Maintenance Planner to optimize PM scheduling.
  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.
• Planning & Continuous Improvement
  Partner with Maintenance Scheduler & Planner to optimize PM scheduling.
  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:
  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

Position Qualifications and Experience Requirements

• Education: Associate's 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 (Microsoft Office applications, Trackwise, SAP, other).
• Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
• Knowledge of multiple problem-solving methods, like Root Cause Analysis methodology (5-Why, Fishbone, FMEA).
• Competencies: Strong analytical and problem-solving skills. Excellent communication abilities. Innovation Leadership Technical Expertise in Asset Management Data-Driven Decision Making Change Leadership & Transformation Cross-Cultural Collaboration Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.

The expected base salary range for this position at hiring is $97,000 - $115,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.