Engineering Senior Officer

FDC Limited - Plant III ( Goa ); South Goa District; On-site; INR 350,000 - 550,000; Full time

Job summary

FDC Limited - Plant III ( Goa ) in Goa, India, seeks an experienced maintenance engineer to oversee cGMP-compliant maintenance of pharmaceutical production equipment. You will manage breakdowns, preventive and predictive maintenance, and shift operations while ensuring SAP work orders and records are up to date.

Responsibilities include HVAC monitoring, equipment qualification/validation per GMP, and supporting regulatory inspections by USFDA/MHRA.

Responsibilities

• Ensure compliance with cGMP, GEP and regulatory requirements.
• Handle breakdown maintenance of pharmaceutical process equipment such as FBE, RMG, Compression machines, Blister Packing machines and other production equipment.
• Execute preventive and predictive maintenance activities as per approved schedules.
• Monitor and manage SAP maintenance notifications, work orders and maintenance records.
• Handle shift engineering operations and ensure timely resolution of equipment-related issues.
• Monitor HVAC systems, including operation, maintenance and performance.
• Coordinate and execute equipment qualification and validation activities in compliance with GMP requirements.
• Support regulatory inspections and ensure engineering systems meet requirements of agencies such as USFDA and MHRA.
• Identify opportunities for automation and engineering improvements to minimize breakdowns, improve equipment reliability and optimize operations.
• Analyze recurring equipment failures and implement effective RCA and CAPA.
• Coordinate with external agencies, vendors and contractors for maintenance, projects and specialized engineering activities.
• Maintain proper engineering documentation, records and compliance as per company procedures.
• Train, guide and develop engineering technicians and subordinate staff.

Skills

cGMP

Regulatory compliance

Preventive maintenance

Predictive maintenance

Root Cause Analysis

CAPA

Equipment troubleshooting

Automation

HVAC management

Documentation

Vendor coordination

Tools

SAP

Job description

• Ensure compliance with cGMP, Good Engineering Practices (GEP) and applicable regulatory requirements.
• Handle breakdown maintenance of pharmaceutical process equipment such as FBE, RMG, Compression machines, Blister Packing machines and other production equipment.
• Execute preventive and predictive maintenance activities as per approved schedules.
• Monitor and manage SAP maintenance notifications, work orders and maintenance records.
• Handle shift engineering operations and ensure timely resolution of equipment-related issues.
• Monitor HVAC systems, including operation, maintenance and performance.
• Coordinate and execute equipment qualification and validation activities in compliance with GMP requirements.
• Support regulatory inspections and ensure engineering systems meet requirements of agencies such as USFDA and MHRA.
• Identify opportunities for automation and engineering improvements to minimize breakdowns, improve equipment reliability and optimize operations.
• Analyze recurring equipment failures and implement effective Root Cause Analysis (RCA) and Corrective/Preventive Actions (CAPA).
• Coordinate with external agencies, vendors and contractors for maintenance, projects and specialized engineering activities.
• Maintain proper engineering documentation, records and compliance as per company procedures.
• Train, guide and develop engineering technicians and subordinate staff.