Associate Director Engineering
3 weeks ago
Develop and implement maintenance strategies aligned with business goals and global standards
Lead cross-functional shutdown planning and execution, including coordination of asset investment programs
Represent the maintenance function in steering committees and regulatory inspections
2. Operational Oversight
Oversee daily maintenance activities for production equipment, utilities, HVAC, cleanrooms, and support systems
Ensure preventive and predictive maintenance programs are executed effectively to minimize downtime and extend equipment life
Manage CMMS systems, work orders, spare parts inventory, and vendor contracts
3. Team Management
Supervise and develop maintenance teams across multiple facilities (e.g., B1–B5, W20)
Conduct training and competency development for technicians and engineers
Drive a culture of safety, compliance, and performance excellence
4. Regulatory & Compliance
Ensure adherence to cGMP, US FDA, EU-GMP, and other global regulatory standards
Lead audit readiness and support inspections by regulatory bodies
Maintain documentation and SOPs for equipment qualification, calibration, and maintenance
5. Continuous Improvement
Apply reliability-centered maintenance, lean, and Six Sigma methodologies to improve asset performance
Analyze maintenance KPIs and implement corrective actions for recurring issues
Drive sustainability initiatives and energy optimization in maintenance operations
6. Qualifications & Skills
- Bachelor's or master's degree in mechanical.
- 20+ years of experience in maintenance leadership within biopharma or regulated industries.
- Expertise in HVAC, utilities, automation systems (e.g., DeltaV, ABB 800xA), and cleanroom operations
- Strong knowledge of CMMS, GAMP 5, ISA-88, and regulatory compliance.
- Proven ability to lead cross-functional teams and manage large-scale projects.
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