Head of Manufacturing Engineering & Maintenance Services

The Head of Site Engineering and Maintenance is accountable for the strategic vision, leadership, and operational excellence of engineering, maintenance, utilities, and facility services across CSL Behring’s global manufacturing network. This role ensures all facilities and equipment operate at optimal efficiency, reliability, and compliance, supporting CSL Behring’s mission to deliver life-saving biopharmaceutical products. The incumbent drives innovation, transformation, and continuous improvement, while maintaining the highest standards of safety, quality, and regulatory compliance.

Main Responsibilities and Accountabilities:

1.Engineering & Maintenance Management

• Direct all aspects of manufacturing engineering and maintenance, including technical support, project management, emergency response, on-call, troubleshooting, and corrective, preventive/predictive maintenance.
• Ensure facilities and equipment are designed, operated, and maintained in compliance with cGMP, Health Authorities (i.e. FDA), EHS, and all applicable local, state, and national regulations and applicable technical norms and standards.
• Drives execution of qualification plans, risk analysis, metrology, data integrity, and general GMP issues, ensuring documentation and compliance standards are met.
• Lead the planning, budgeting, execution, and commissioning of major capital projects, facility expansions, and technology upgrades
• Champion asset lifecycle management, reliability engineering, and the implementation of best-in-class maintenance practices.
• Oversees sites workshop operations, ensuring availability of adequate tools as well as safe and compliance workplace practices

2. Strategic Leadership & Vision

• Develop, communicate, and execute a engineering and maintenance strategy aligned with CSL Behring’s long-term business objectives and regulatory requirements.
• Lead transformation initiatives, including digitalization, advanced automation, sustainability, and adoption of cutting-edge manufacturing technologies.
• Supports the development and implementation of multi-year strategic plans, capital investment roadmaps, and operational readiness programs for all global sites.
• Serve as a key member of the global manufacturing leadership team, contributing to enterprise-wide strategy and decision-making.

3. 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.

4. Operational Excellence & Metrics

• Develop, monitor, and report on Key Performance Indicators (KPIs) for engineering and maintenance, including reliability, efficiency, cost, safety, and compliance.
• Analyze operational data to identify trends, risks, and opportunities for improvement.
• Implement COS, Six Sigma, Lean, and other continuous improvement methodologies to optimize processes and eliminate non-value-added activities.
• Drive the adoption of new technologies and best practices to enhance operational performance and cost-effectiveness.
• Conducts regular GEMBAS and ensures self-inspections are conducted

5. Facility Services

• Oversee the management of GMP/non-GMP facility systems, ensuring uninterrupted support for manufacturing operations.
• Ensure robust emergency response protocols and business continuity plans are in place for critical utilities and infrastructure.
• Manage relationships with external service providers, contractors, and vendors to ensure high-quality, cost-effective service delivery.

Collaboration & Stakeholder Engagement

• Partner with Manufacturing, Quality, EHS, Supply Chain, IT, and other departments to support site-wide and enterprise-wide operational objectives.
• Engage with global and regional leadership, peers at other sitesto align manufacturing engineering and maintenance strategies with broader business goals.
• Analyze, present alternatives, make recommendations, and provide expert assistance for improving production and business processes.

Digitalization & Data Analytics

• Champion the use of digital tools and data analytics (e.g., SAP, Trackwise, Ariba, Power BI, Smart Sheet, Tableau) to enhance decision-making and operational transparency.
• Ensure systems are integrated, secure, and support real-time monitoring and reporting of facility and equipment performance.
• Adopt industry trends, i.e., predictive maintenance, and implement solutions striving to optimize asset uptime and reliability

Risk Management & Business Continuity

• Identify, assess, and mitigate risks related to manufacturing engineering and maintenance operations.
• Develop and maintain robust business continuity and disaster recovery plans for all critical infrastructure.

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.
• Provide coaching, feedback, and developmental opportunities to team members at all levels.

Operational Budgets

• Oversees assigned cost centers, monitors performances, acts on trends, and ensures adherence to budgets
• Develops budgets for OpEx and headcounts
• Ensures financial compliance (i.e. SOx) within the area of responsibility
• Constantly strives for improving effective and efficient operations of the manufacturing engineering and maintenance function, impacting the budgets

Completes any other duties/responsibilities assigned by senior management

Education

• Bachelor’s degree in engineering (Chemical, Mechanical, Electrical) required, a master’s preferred.

Experience

• Minimum of 10+ years’ experience in the pharmaceutical, food, or chemical process industry.
• At least 5+ years of technical management or leadership experience, including effective collaboration with a cross-functional group.
• Significant expertise in GMP/non-GMP manufacturing assets related to pharmaceutical production.
• Expertise in sterile manufacturing, bulk production and finishing and packaging operations of (bio)pharmaceuticals preferred
• Experience managing union and non-union workforces preferred, where applicable.
• Advanced skills in facility management systems (Trackwise, SAP, FMS, Ariba, DCMS) and digital tools (MS Project, Excel, Power BI, Smart Sheet, Tableau).
• Knowledge of Six Sigma/Lean principles is a plus.
• Financial acumen in managing multimillion-dollar budgets.
• Experience with global health authorities inspections and audits as well as interactions with regulatory agencies
• Ability to lead cross-functional teams and manage multiple projects.
• Strategic thinker with a proactive approach to problem-solving.

Competencies

• Technical Engineering Expertise
• Capital Planning and Execution
• Stakeholder and Cross-Functional Collaboration
• Compliance and Risk Management
• Operational Excellence
• Communication and Executive Influence

About CSL Behring

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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our 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 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.