Associate Director Engineering

8 hours ago

bangalore, India Biocon Biologics Full time

1. Strategic Leadership

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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