About the role

Job Title

Engineering Officer / Maintenance Engineer

Key Responsibilities

1. HVAC & Utilities Management
- Operate, maintain, and troubleshoot HVAC systems (AHUs, chillers, cooling towers, HEPA filters, ducting, VFDs).
- Ensure temperature, humidity, differential pressure, and air change rates meet GMP requirements.
- Monitor and maintain cleanroom classifications and environmental controls.
- Coordinate filter integrity testing (PAO/DOP), airflow balancing, and HVAC validation activities.
2. Equipment & Machinery Maintenance
- Maintain pharmaceutical manufacturing, packing, and utility equipment to ensure minimum downtime.
- Execute preventive, predictive, and breakdown maintenance as per approved schedules.
- Maintain calibration support for equipment and instruments (coordination with QA/Calibration team).
- Ensure proper installation, commissioning, and qualification of new equipment.
3. GMP & Regulatory Compliance
- Ensure all engineering activities comply with WHO-GMP, US FDA, EU GMP, and local regulatory norms.
- Prepare, review, and maintain SOPs, logbooks, maintenance records, and deviation reports.
- Support regulatory audits, customer audits, and internal inspections.
- Participate in change control, deviation, CAPA, and risk assessment activities.
4. Utilities & Facility Systems
- Operate and maintain utilities such as:
- Ensure uninterrupted utility supply for production operations.
5. Safety & Energy Management
- Ensure compliance with safety standards, including electrical and mechanical safety.
- Implement energy-saving initiatives and optimize utility consumption.
- Ensure safe handling of tools, spares, and maintenance activities.
6. Vendor & Spare Management
- Coordinate with OEMs, AMC vendors, and service providers.
- Manage spare parts inventory and ensure availability of critical spares.
- Evaluate vendor performance and service quality.

Qualifications & Experience

Educational Qualification: Diploma / BE / B.Tech in Mechanical, Electrical, HVAC, or Instrumentation Engineering.
Experience: 2–8 years of experience in pharmaceutical, API, formulation, or regulated manufacturing facility.
Hands-on experience with GMP-compliant HVAC systems and pharmaceutical utilities.

Skills & Competencies

Strong knowledge of pharma HVAC and cleanroom systems
Understanding of GMP, validation, and regulatory documentation
Troubleshooting and problem-solving skills
Ability to work in audit-driven environments
Basic computer skills (MS Excel, maintenance software)

Key Performance Indicators (KPIs)

Equipment uptime and breakdown frequency
HVAC and utility compliance
Audit observations related to engineering
Preventive maintenance adherence
Energy efficiency improvements