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 servicesacross CSL Behrings global manufacturing network. This role ensures all facilities and equipment operate at optimal efficiency reliability and compliance supporting CSL Behrings 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 Behrings 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 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.

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

• Bachelors degree in engineering (Chemical Mechanical Electrical) required a masters 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 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