Position: Maintenance Engineer

Location: Vapi

Experience: 2 - 5 Years

Industries: Pharma - API

Responsibilities

- Core Documentation Responsibilities
- Equipment Facility Documentation
- Maintain and control engineering drawings, PIDs (Piping Instrumentation Diagrams), equipment manuals, and spare parts lists
- Manage equipment qualification documents (IQ, OQ, PQ) and requalification schedules
- Create and update equipment files, asset registers, and technical specifications
- Maintenance Documentation
- Develop and maintain Preventive Maintenance (PM) procedures and schedules
- Write and revise Standard Operating Procedures (SOPs) for maintenance activities
- Manage work order documentation, maintenance logs, and equipment history records
- Document corrective and breakdown maintenance activities in the CMMS (Computerized Maintenance Management System)
- GMP Regulatory Compliance
- Ensure all documentation complies with cGMP (21 CFR Part 211, ICH Q7) requirements for API manufacturing
- Support preparation and review of documentation for regulatory audits (FDA, EMA, WHO)
- Maintain documentation for calibration programs (instruments, gauges, sensors)
- Manage change control documentation for engineering modifications
- Participate in deviation and CAPA documentation related to equipment failures
- Document Control Management
- Control document lifecycle ; creation, review, approval, distribution, revision, and archiving




- Maintain document management systems (DMS/EDMS like Veeva, Documentum, MasterControl)
- Track document revision history and ensure obsolete documents are withdrawn
- Coordinate document review cycles with engineering, production, QA, and validation teams
- Validation Qualification Support
- Prepare and compile Validation Master Plans (VMP), qualification protocols, and summary reports
- Support CSV (Computer System Validation) documentation for engineering-related software
- Maintain utilities qualification records (HVAC, WFI, purified water, compressed air, steam)
- Spare Parts Vendor Documentation
- Maintain vendor/supplier technical documentation and certificates
- Manage critical spare parts lists with OEM specifications
- File and track equipment warranties and service contracts
- Cross-Functional Coordination
- Liaise with QA, Production, EHS, and Validation teams for document approvals
- Support internal and external audits by providing required documentation
- Train maintenance and engineering staff on documentation procedures

Required Skills
- Preventive Breakdown Maintenance
- PID Engineering Drawings
- SOP CMMS Documentation
- IQ/OQ/PQ Validation
- Calibration Qualification
- cGMP Compliance
- Change Control, Deviation CAPA
- Spare Parts Vendor Management
- Audit Documentation Support

Required Qualification

Diploma/B.E/B.Tech - Mechanical/Electrical

Key Skills

- Sop
- Gmp
- Documentation
- Regulatory Compliance

📌 Maintenance Engineer (Vapi)
🏢 Quality HR Services
📍 Vapi