Director of Manufacturing Engineering and Maintenance

CSL; Kankakee (IL); On-site; USD 199,000 - 244,000; Full time

Job summary

CSL in Illinois seeks a Head of Manufacturing Engineering & Maintenance to lead the reliability and lifecycle management of manufacturing assets. This role oversees Calibration & Metrology, Manufacturing Maintenance, Reliability Engineering, Production/System Owner Engineering, and Shutdown Planning & Scheduling, with a focus on regulatory readiness in biopharma.

You will mentor engineers and maintenance teams, champion Lean and Six Sigma, and partner with Quality, MS&T, EHS, and Supply Chain to

Qualifications

• Bachelor's degree in Engineering required.
• 12+ years of engineering in Biotech/Pharma or regulated life sciences.
• 8+ years leading engineers or technical teams.
• Strong GMP, validation, and regulatory understanding.
• Experience with reliability engineering and CMMS systems.
• Six Sigma/Lean knowledge a plus.
• Biotech manufacturing process familiarity and automation/digitization experience.

Responsibilities

• Provide strategic leadership for site engineering & maintenance.
• Develop and implement engineering/maintenance strategy for asset performance & lifecycle management.
• Lead and develop a high-performing organization focused on safety and continuous improvement.
• Direct manufacturing engineering and maintenance activities, including support, projects, emergency response, and maintenance.
• Oversee capital projects lifecycle from conception to commissioning.
• Develop enterprise reliability strategies (RCM, FMEA, PdM, CMMS optimization).
• Drive KPIs, dashboards, and continuous improvement initiatives.
• Support site capital projects, plant turnarounds, and asset qualification/handovers.
• Ensure GMP and regulatory compliance in manufacturing engineering and maintenance.

Skills

Leadership

GMP Knowledge

Reliability Engineering

CMMS

Budgeting

Cross-functional

Analytics

Education

Bachelor's degree in Engineering

Tools

CMMS software

Automation systems

Job description

Position Purpose

Provide an overview of the responsibilities of the position by providing a summary of the most critical aspects and duties of the position. The Head of Manufacturing Engineering & Maintenance is a strategic leader responsible for the reliability and lifecycle management of manufacturing assets. This role oversees Calibration & Metrology Engineering, Manufacturing Maintenance, Reliability Engineering, Production/System Owner Engineering, and Shutdown Planning & Scheduling. Key responsibilities support critical operations, including fractionation, bulk production, and packaging, while ensuring equipment readiness and compliance with regulatory standards in the biopharmaceutical sector. The position also requires strong skills in labor relations to foster collaboration within a unionized workforce.

Reporting Relationships

Role that this position reports to: Engineering & Maintenance Site Head

Role/s that report to this position: Engineers, Maintenance, Calibrations, Shutdown Planner

Main Responsibilities and Accountabilities

• Engineering Leadership
• Develop and implement the site engineering and maintenance strategy aligned with CSL enterprise objectives, ensuring optimal asset performance and lifecycle management
• Lead and develop a high-performing organization, fostering a culture of accountability, safety, and continuous improvement
• Direct all aspects of manufacturing engineering and maintenance, including technical support, project management, emergency response, on-call, troubleshooting, and corrective, preventive/predictive maintenance.
• Supports the development and implementation of multi-year strategic plans, capital investment roadmaps, and operational readiness programs for all global sites
• Additionally, you will support capital projects throughout their entire lifecycle, from conception and planning to execution and commissioning, ensuring that each project aligns with organizational objectives and is completed successfully.
• Strategy Reliability & Asset Management Vision
• Develop and execute enterprise-level reliability strategies (RCM, FMEA, PdM, CMMS optimization)
• Enhance the accessibility of assets, maximize operational uptime, and optimize the overall cost performance throughout their lifecycle.
• Analyze equipment failures and lead root cause analysis (RCA) and corrective actions
• Establish asset health monitoring and performance metrics
• Continuous Improvement
• Drive continuous improvement initiatives leveraging Lean, Six Sigma, and reliability-centered methodologies
• Explore and pinpoint areas where automation can enhance efficiency, digitization can streamline processes, and predictive maintenance can optimize equipment performance.
• Additionally, create and monitor KPIs for engineering activities, along with comprehensive dashboards to visualize and track these metrics effectively.
• Capital Projects & Technical Execution
• Support site capital projects, including equipment installation and AMP upgrades,
• Provide oversight for planning and execution of site shutdowns and turnarounds, ensuring adherence to scope, schedule, cost, and safety requirements
• Ensure proper design, qualification, and handover of assets to engineering and maintenance operations
• Quality Management & Regulatory Compliance
• Ensure quality management procedures within manufacturing engineering and maintenance, with a focus on cGMP and GEP requirements, are implemented.
• Leads the site's manufacturing engineering and maintenance organization, ensuring assets and services are in compliance with GMP and regulatory standards and product filings.
• Oversee deviation management, investigation of deviations, and establishment of corrective and preventive actions for critical systems.
• Represent the local manufacturing engineering and maintenance function in regulatory inspections, audits, and ensure areas within the area of responsibility remain audit-ready.
• Cross-Functional Collaboration
• Partner with Manufacturing, Quality, MS&T, EHS, and Supply Chain to support production goals, resolve technical challenges, and improve process performance
• Engage with global and regional leadership, peers at other sites to align manufacturing engineering and maintenance strategies with broader business goals.
• Team Leadership & Development
• Lead, mentor, and develop a diverse, cross-functional team of engineers, maintenance professionals, and quality specialists on site.
• Foster a positive, equitable, and inclusive working environment, emphasizing CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
• Develop succession plans and talent pipelines to ensure organizational resilience and leadership continuity.
• Perform other duties as assigned by the supervisor, members of the Global Leadership Team, or other authorized leaders in support of evolving business needs and cross-functional collaboration.

Position Qualifications and Experience Requirements

Education

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Biochemical, or related discipline) is required

Experience

• 12+ years of engineering experience in Biotech, Pharma, or regulated life sciences.
• 8+ years leading engineers or technical teams
• Strong understanding of GMP, validation, and regulatory expectations
• Experience with reliability engineering, maintenance strategies, and CMMS systems
• Knowledge of Six Sigma/Lean principles is a plus.
• Knowledge of biotech manufacturing processes (upstream/downstream/fill-finish as applicable)
• Familiarity with automation and digital systems
• Financial experience with high-level budgetary responsibilities is required
• Strategic thinker with the ability to translate complex engineering challenges into actionable programs

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
• Financial Acumen & ROI-oriented mindset
• 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 $199,000 - $244,000. 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.