Director of Manufacturing Engineering and Maintenance

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 sites 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

• Bachelors 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 $199000 - $244000. 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 addition to base salary total compensation for this role may also include incentive compensation and equity.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

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

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 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 Experience:

Director