Engineering Manager

Job Description Summary

Sound knowledge on Handling of HVAC and utilities related to injectable .

Job Description

• HVAC Systems Management:
  
  

Design, implement, and maintain HVAC systems to meet cleanroom classifications (ISO 5–8) and regulatory requirements (USFDA, EU-GMP, WHO-GMP).

• Utilities Oversight:
  
  

Manage critical utilities including WFI, RODI, Pure Steam, Compressed Air, Nitrogen, and chilled water systems. Ensure continuous availability and compliance with pharmacopeial standards.

• Preventive & Breakdown Maintenance:
  
  

Develop and execute preventive maintenance schedules. Lead root cause analysis and corrective actions for equipment failures.

• Regulatory Compliance:
  
  

Ensure all systems and documentation comply with cGMP, GEP, and audit requirements. Participate in regulatory inspections and internal audits.

• Project Management:
  
  

Lead utility and HVAC-related projects including capacity expansion, energy optimization, and technology upgrades.

• Team Leadership:
  
  

Supervise and mentor a team of engineers and technicians. Foster a culture of safety, quality, and continuous improvement.

• Documentation & QMS:
  
  

Maintain SOPs, calibration records, change controls, and deviation reports. Work within QMS platforms like Track wise or SAP.