Director of Manufacturing Engineering and Maintenance

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

Job summary

CSL Plasma Inc. seeks a seasoned Head of Manufacturing Engineering & Maintenance to lead reliability, lifecycle management, and capital projects for fractionation, bulk production, and packaging.

You will oversee Calibration & Metrology, Maintenance, Reliability, and Shutdown Planning, ensuring asset readiness and regulatory compliance in a unionized environment. The role requires extensive experience in biotech/manufacturing, strong leadership, and a strategic mindset to drive capital planning,

Qualifications

• Bachelor’s degree in Engineering is required.
• 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).
• Familiarity with automation and digital systems.
• Financial experience with high-level budgetary responsibilities is required.

Responsibilities

• Develop and implement the site engineering and maintenance strategy.
• Lead and develop a high-performing engineering and maintenance organization.
• Oversee capital projects lifecycle from planning to commissioning.
• Ensure GMP and regulatory compliance across assets and processes.
• Establish asset health metrics and drive RCA-based improvements.
• Drive Lean, Six Sigma, and digitization initiatives.
• Collaborate with cross-functional teams to achieve production goals.

Skills

Engineering leadership

Strategic thinking

Analytical skills

Communication

Problem solving

Financial acumen

Change leadership

Cross-cultural collaboration

Education

Bachelor’s degree in Engineering

Tools

CMMS systems

Automation & digitization tools

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

1. 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.

2. 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

3. 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.

4. 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

5. 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.

6. 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.

7. 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.

8. 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

Provide the hiring requirements for the specified position, including educational, experiential, and competency 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.

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.

Salary

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.

Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

Inclusion and Belonging

You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.