Director of Manufacturing Engineering and Maintenance
Listed on 2026-07-11
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Engineering
Operations Management, Quality Engineering, Regulatory Compliance Specialist
Position Purpose
The Head of Manufacturing Engineering & Maintenance is a strategic leader responsible for the reliability and lifecycle management of manufacturing assets within the biopharmaceutical sector. The role oversees Calibration & Metrology Engineering, Manufacturing Maintenance, Reliability Engineering, Production/System Owner Engineering, and Shutdown Planning & Scheduling, ensuring equipment readiness and compliance with regulatory standards.
Reporting RelationshipsReports to:
Engineering & Maintenance Site Head
Direct reports:
Engineers, Maintenance, Calibrations, Shutdown Planner
- 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, and predictive maintenance.
- Support the development and implementation of multi‑year strategic plans, capital investment roadmaps, and operational readiness programs for all global sites.
- Support capital projects throughout their entire lifecycle, from conception and planning to execution and commissioning, ensuring alignment with organizational objectives.
- Execute enterprise‑level reliability strategies (RCM, FMEA, PdM, CMMS optimization).
- Enhance asset accessibility, maximize operational uptime, and optimize overall cost performance throughout lifecycle.
- Analyze equipment failures and lead root cause analysis and corrective actions.
- Establish asset health monitoring and performance metrics.
- Drive initiatives leveraging Lean, Six Sigma, and reliability‑centered methodologies.
- Identify opportunities for automation, digitization, and predictive maintenance to enhance efficiency.
- Create and monitor KPIs for engineering activities, and develop dashboards to visualize these metrics.
- Support site capital projects, including equipment installation and AMP upgrades.
- Oversee 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.
- Implement quality management procedures within manufacturing engineering and maintenance, focusing on cGMP and GEP requirements.
- Ensure assets and services are compliant with GMP and regulatory standards, managing deviations, investigations, and corrective and preventive actions.
- Represent the function in regulatory inspections and audits, maintaining audit readiness.
- Partner with Manufacturing, Quality, MS&T, EHS, and Supply Chain to support production goals and resolve technical challenges.
- Engage with global and regional leadership and peers at other sites to align strategies with broader business goals.
- Lead, mentor, and develop a diverse, cross‑functional team of engineers, maintenance professionals, and quality specialists.
- Foster a positive, equitable, and inclusive environment, emphasizing CSL values.
- Develop succession plans and talent pipelines for organizational resilience.
- Perform additional duties as assigned by the supervisor, Global Leadership Team, or authorized leaders to support evolving business needs.
- Education:
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Biochemical, or related discipline). - Experience:
12+ years of engineering experience in Biotech, Pharma, or regulated life sciences; 8+ years leading engineers or technical teams. - Knowledge: GMP, validation, and regulatory expectations; reliability engineering, maintenance strategies, and CMMS systems;
Six Sigma/Lean principles; biotech manufacturing processes (upstream/downstream/fill‑finish); automation and digital systems. - Financial:
High‑level budgetary responsibilities and ROI orientation. - Competencies:
Strong analytical and problem‑solving skills; excellent communication; innovation, leadership, technical expertise, data‑driven decision making, change leadership, cross‑cultural collaboration, financial acumen, and commitment to CSL values.
The expected base salary range for this position at hiring is $199,000 – $244,000.
Equal Opportunity EmployerCSL 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
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