Role & responsibilities

Equipment Maintenance

- Plan and execute preventive, predictive, and breakdown maintenance of production equipment.
- Ensure maximum equipment uptime and reliability.
- Troubleshoot mechanical failures and implement corrective actions.
- Monitor equipment performance and recommend improvements.

Utility Systems
- Maintain pharmaceutical utility systems, including:

- HVAC systems

- Chillers

- Boilers

- Air Compressors

- Cooling Towers

- Vacuum Systems

- Water Pumps

- AHUs

- Purified Water (PW) systems
- Water for Injection (WFI) systems (where applicable)
- Monitor utility consumption and optimize energy efficiency.

Installation & Qualification
- Supervise installation and commissioning of current equipment.
- Support equipment qualification activities:

- Installation Qualification (IQ)

- Operational Qualification (OQ)

- Performance Qualification (PQ)
- Coordinate with validation and QA teams during qualification activities.

Preventive Maintenance
- Develop preventive maintenance schedules.
- Maintain maintenance records and history cards.
- Ensure calibration and servicing are completed as per schedule.
- Improve maintenance planning using CMMS where available.

GMP & Regulatory Compliance
- Ensure compliance with:

- GMP

- GLP

- SOPs

- Safety procedures

- Company engineering standards
- Support regulatory inspections and customer audits.
- Prepare documentation required during audits.

Documentation
- Prepare and maintain:

- SOPs





- Preventive maintenance checklists

- Breakdown reports

- Equipment history records

- Spare parts records
- Root Cause Analysis (RCA) reports

- CAPA documentation

- Maintenance logs

Spare Parts Management
- Identify critical spare parts.
- Monitor spare inventory levels.
- Coordinate procurement of mechanical spares.
- Reduce downtime through effective inventory planning.

Continuous Improvement
- Conduct Root Cause Analysis (RCA) for recurring equipment failures.
- Implement CAPA.
- Participate in Lean, Kaizen, TPM, and energy-saving initiatives.
- Improve Overall Equipment Effectiveness (OEE).

Safety Responsibilities
- Follow EHS policies and safe work practices.
- Conduct risk assessments before maintenance work.
- Ensure proper Lockout/Tagout (LOTO) procedures.
- Maintain a safe and clean work environment.

Required Qualifications

Preferred candidate profile

Technical Skills

- Mechanical maintenance of pharmaceutical equipment
- HVAC systems
- Boilers and steam systems
- Chillers and cooling systems
- Air compressors
- Pumps and piping systems
- Preventive and predictive maintenance
- CMMS software
- AutoCAD (preferred)
- Equipment qualification (IQ/OQ/PQ)
- Root Cause Analysis (RCA)
- CAPA implementation
- OEE improvement
- GMP documentation
- Utility management
- Energy conservation

Education
- B.E./B.Tech in Mechanical Engineering
- Diploma in Mechanical Engineering (for junior positions)

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