Purpose
To plan, lead, and manage all utility maintenance engineering activities to ensure high equipment reliability, regulatory compliance, operational efficiency, and uninterrupted utilities management in a pharmaceutical formulation manufacturing facility.
Position / Job Title
Assistant Manager – Utility Maintenance, Engineering
Department
Engineering
Reporting To
Assistant General Manager, Engineering
Location
Indore
Years Of Experience
9–12 years of experience in Utility maintenance engineering
Dosage Form Solid & Semi solid
Job Responsibilities / Deliverables
Utility Operations Management
- Operate and maintain all plant utility systems including Chillers, Boilers, Air Compressors, WTP, ETP, Cooling Towers, Substation, Transformers, DG Sets, and UPS.
- Ensure uninterrupted availability of utilities to support manufacturing, labs, HVAC, and critical operations.
- Manage shift operations and ensure 24×7 utility coverage through proper manpower deployment.
- Support Production, QA, and Engineering teams during operational requirements.
- Ensure availability and compliance of all critical utilities during inspections and audits.
Maintenance Planning & Execution
- Plan and execute preventive, predictive, and breakdown maintenance for all utility equipment.
- Monitor daily utility performance parameters and take corrective actions as required.
- Plan and manage spares, consumables, and inventory for utility maintenance.
- Coordinate with vendors, contractors, and service providers for maintenance activities.
- Investigate utility breakdowns and perform root cause analysis (RCA) with preventive actions.
- Drive continuous improvement initiatives for reliability and efficiency of utilities.
Compliance, QMS & Documentation
- Prepare and maintain all GMP and GDP documentation for utility systems.
- Ensure strict compliance with ALCOA++ principles across all utility records.
- Prepare, review, and update SOPs, logbooks, checklists, formats, and controlled documents.
- Handle Deviations, CAPA, Change Controls, Investigations related to utility operations.
- Support and face USFDA, regulatory, and customer audits pertaining to utilities.
- Ensure continuous audit readiness of all utility areas and documentation.
- Ensure 100% compliance with Pharma GMP and regulatory expectations.
- Prepare quarterly and monthly technical reports, trend analysis, and presentations using MS Office.
- Maintain and review daily/weekly/monthly utility performance reports.
Qualification, Validation & Calibration
- Coordinate qualification, validation, and requalification activities for utility systems.
- Prepare, review, and update utility layouts and engineering drawings using AutoCAD.
Safety, EHS & Statutory Compliance
- Ensure compliance with EHS and safety standards, including LOTO, Hot Work, PTW, and equipment safety norms.
- Ensure proper housekeeping and 5S implementation in utility areas.
- Ensure statutory compliance related to boilers, pressure vessels, DG sets, and electrical systems.
- Monitor compliance with all legal and statutory EHS requirements during utility and maintenance activities.
Shift Leadership & Team Management
- Supervise and guide shift engineers and technicians, ensuring effective task allocation.
- Conduct training and skill development programs for utility personnel.
- Promote a culture of quality, safety, ownership, and compliance within the utility team.
Digital Systems & SAP
- Use SAP for PR/PO creation, maintenance planning, work order management, and spare part tracking.
Energy & Operational Efficiency
- Monitor and control energy consumption, implementing optimization and cost-saving initiatives.
Regulatory Compliance & GMP
- Ensure compliance with cGMP, WHO-GMP, USFDA, EU-GMP, and other regulatory requirements
- Support regulatory inspections, audits, and CAPA implementation
- Ensure proper documentation of maintenance records, logbooks, and change controls
Qualifications Education
- Bachelor's degree in mechanical engineering
- Project Management is an advantage
Additional Notes Skills & Competencies
- Strong knowledge of pharma manufacturing equipment and utilities
- In-depth understanding of GMP and regulatory compliance
- Leadership and people management skills
- Problem-solving and analytical abilities
- Budgeting, planning, and project management skills
- Familiarity with CMMS and maintenance planning tools
Key Performance Indicators (KPIs)
- Equipment uptime and reliability
- Maintenance cost optimization
- Regulatory audit outcomes
- Compliance to preventive maintenance schedules
- AOP Budget Tracking & Management
