Global Director Maintenance Innovation & Reliability Excellence

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 Global Director of Maintenance Innovation & Reliability Excellence plays a crucial role in

developing the maintenance and reliability strategy for the biopharmaceutical manufacturing

network. This leader fosters a culture of maximizing equipment uptime through predictive

maintenance and digital innovation while ensuring regulatory compliance with GMP and safety

standards. The director oversees global programs, establishes standards, and integrates advanced

technologies to improve equipment reliability, minimize downtime, and optimize maintenance

costs. Through strategic leadership, the Global Director drives continuous improvement and

operational excellence in the biopharmaceutical industry.

Main Responsibilities and Accountabilities: List the roles and responsibilities of the position

1 Global Maintenance & Reliability Strategy § Construct and execute a comprehensive global strategy for maintenance and reliability excellence that aligns seamlessly with the goals of manufacturing, quality, and overall business objectives. § Establish and uphold global standards for asset management, including guidelines such as GAMP, ISO 55000, and CMMS standards, ensuring consistency and best practices across all operations. § Spearhead the development of multi-year roadmaps focused on predictive maintenance (PdM), condition monitoring, and the management of digital asset performance, driving innovation and efficiency in maintenance practices.

2 Innovation & Technology Leadership § Assess, test, and implement cutting-edge maintenance technologies, such as Internet of Things (IoT) sensors, artificial intelligence-driven monitoring systems, smart instrumentation, and digital twin models to enhance operational efficiency. § Collaborate closely with automation, digital transformation, and engineering teams to integrate Industry 4.0 methodologies into biopharmaceutical operations, ensuring a seamless transition to more advanced manufacturing practices. § Advocate for innovative approaches in managing the equipment lifecycle, optimizing spare parts inventory, and executing maintenance tasks effectively, ultimately leading to improved reliability and performance of biopharma assets.

3 Reliability Program Management § Establish global reliability engineering frameworks (RCM, FMEA, CBM, asset criticality ranking). § Monitor fleet performance of critical assets (filter press, chromatography skids, HVAC/clean utilities, filling/packaging systems, etc.). § Support root-cause investigations for high-impact equipment failures and ensure closure of corrective/preventive actions.

4 Maintenance Excellence & Continuous Improvement § Standardize maintenance processes across all manufacturing sites by developing and implementing preventive and predictive maintenance programs, effective work order management, and calibration procedures. § Support global maintenance KPI reporting on key metrics like MTBF, MTTR, OEE for equipment and production lines, compliance with PM schedules, and downtime analysis. § Promote continuous improvement using Lean, Six Sigma, and operational excellence principles to enhance maintenance efficiency and effectiveness. § Evaluate business cases and ROI for reliability improvements, system upgrades, and digital investments.

5 Compliance, Quality & Safety § Ensure global maintenance practices comply with GMP, GEP, FDA/EMA/ICH guidance, and corporate EHS policies. § Support regulatory inspections and audits related to equipment, utilities, and maintenance systems. § Promote a culture of safety, data integrity, and audit readiness.

Leadership & Cross-Functional Collaboration § Support the team of reliability engineers and maintenance experts to improve operational efficiency and reliability. § Foster strong collaborative relationships with Site Engineering Heads, as well as key stakeholders in Quality Assurance, Supply Chain Management, and Digital/Automation initiatives to ensure seamless integration and alignment of objectives. § Oversee the management of global vendor partnerships, including the negotiation and administration of service contracts and the cultivation of strategic technology alliances, to drive innovation and enhance service delivery.

Risk Management & Business Continuity § Develop, identify, assess, and mitigate risks related to engineering, maintenance, and facility 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 across global sites. § 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. § Instill a high-performance culture focused on safety, learning, reliability, and innovation.

Completes any other duties/responsibilities assigned by senior management

Education

§ 10+ years of engineering experience in pharmaceutical operations, including familiarity with regulatory compliance, engineering, or reliability roles, including at least 3 years in a global or multi-site leadership position. § 8-10 years' managerial experience, preferably in the pharmaceutical industry § Experience in biopharma, biotech, vaccine, sterile manufacturing, or related GMP-regulated industries is required.

Experience

§ Strong project leadership, vendor management, and cross-functional influence § Improvement in global reliability metrics (MTBF, MTTR, optimal PM/PdM balance) § Strong experience with digital transformation initiatives (AI, predictive analytics, smart factories, etc.). § Demonstrated success in leading large multicultural teams and managing global portfolios. § Exceptional stakeholder management, communication, and strategic planning capabilities. § Expertise in GMP/non-GMP utilities and facilities related to pharmaceutical production. § Knowledge of Six Sigma/Lean principles is a plus. § Strategic thinker with the ability to translate complex engineering challenges into actionable programs

Competencies

§ Strategic & Systems Thinking § Innovation Leadership § Technical Expertise in Asset Management § Data-Driven Decision Making § Change Leadership & Transformation § Cross-Cultural Collaboration § Executive Communication § Financial Acumen & ROI-oriented mindset

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.