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

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