
Systems Utility Leadership Position
1 week ago
The Operations Manager is responsible for leading and managing utility systems in a manufacturing facility. The candidate should have strong experience in pharmaceutical utility operations, maintenance, high standards of safety and regulatory compliance.
Key Responsibilities:
- Oversee the operation and maintenance of all utility systems including Brine chillers, Air compressors, HVAC, N2 plant, Air dryer Chilled water chillers, etc.
- Ensure 24x7 availability of utilities for uninterrupted manufacturing.
- Plan and implement preventive and breakdown maintenance schedules.
- Ensure all utility operations comply with cGMP, USFDA, and other regulatory standards.
- Lead utility qualifications (IQ/OQ/PQ) and support audits and inspections.
- Coordinate with engineering, production, and QA/QC for smooth plant operations.
- Manage energy efficiency, safety, and sustainability initiatives.
- Guide and train the utility team for skill development and compliance
Maintenance & Troubleshooting:
- Perform troubleshooting of instruments and equipment.
- Responsible for breakdown maintenance and preparation of breakdown analysis reports.
- Monitor and reduce the equipment breakdowns through close observation and analysis.
- Ensure preventive and proactive maintenance to avoid equipment failure.
- Maintain spares for critical instruments to ensure smooth plant operations.
Documentation & Reporting:
- Prepare and review SOPs, daily/monthly reports, and handle deviations and change control forms (CCFs).
- Generate SAP indents and consumption reports as per site requirements.
- Support GMP Pro software system documentation and tasks.
CSV and Qualification Activities:
- Handle CSV-related documentation for water systems and process equipment.
- Review qualification documents for utilities and process equipment.
- Participate in qualification and commissioning activities of new systems and equipment.
Material Handling & SAP:
- Responsible for PRN initiation, material indenting, and stock monitoring in SAP.
- Crosscheck incoming materials without POs to ensure accuracy and quality.
Team Supervision & Coordination:
- Oversee engineering team operations in individual API/Pharma blocks.
- Allocate work orders, monitor progress, and ensure timely completion.
- Assist the Engineering Manager with day-to-day responsibilities.
Safety & Compliance:
- Follow safety permit procedures including Hot Work, Vessel Entry, Work at Height, and Excavation permits.
- Ensure 100% equipment availability through structured preventive maintenance.
- Implement corrective and preventive actions (CAPA) within defined timelines.
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