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 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.
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

• Bachelor’s 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.