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:
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
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.
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.
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
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 (https://www.csl.com/careers/your-well-being) .
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 .
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement
