Urgent Openings in Maintenance Validation - IIEPL - Sri city

Role & responsibilities

• Prepare and execute Validation Master Plans (VMP) and equipment validation protocols.
• Perform DQ, IQ, OQ and PQ activities for equipment, utilities, and engineering systems as applicable.
• Validate production and maintenance equipment such as:
• HVAC systems
• Compressors
• Boilers
• Chillers
• AHUs
• Purified Water / WFI systems
• Electrical systems
• Manufacturing and packaging equipment
• Prepare and review URS, DQ, FAT, SAT, IQ, OQ and PQ documents.
• Coordinate with QA, Production, Engineering, QC and external vendors during validation activities.
• Ensure calibration and qualification of critical instruments and equipment.
• Develop and maintain SOPs, validation protocols, reports and checklists.
• Perform requalification of equipment and utilities as per approved schedules.
• Investigate validation failures, deviations, and out-of-specification results related to engineering systems.
• Support CAPA, change control and deviation management activities.
• Ensure all validation documents are complete, accurate, traceable and compliant with GMP requirements.
• Review equipment modifications and assess their impact on the validated state.
• Maintain validation records, equipment history files and qualification documentation.
• Support internal, customer and regulatory audits by providing validation and engineering documentation.
• Monitor preventive maintenance activities for critical GMP equipment and utilities.
• Ensure engineering activities comply with safety, GMP and regulatory requirements.
• Coordinate with vendors and contractors for commissioning, qualification and validation activities.
• Prepare periodic validation status reports and compliance dashboards.

Preferred candidate profile

• Equipment and utility qualification
• IQ/OQ/PQ execution
• Validation documentation
• GMP compliance
• HVAC and utility systems knowledge
• Calibration and preventive maintenance
• Root Cause Analysis
• Change Control and CAPA
• Audit readiness
• Documentation and reporting
• Vendor coordination
• MS Excel and MS Office