Maintenance Engineer

Job Description:

Position:        Maintenance Engineer

Location:       Vapi

Experience:    2 - 5 Years

Industries:     Pharma - API

Responsibilities:

• Core Documentation Responsibilities
• Equipment & Facility Documentation
• Maintain and control engineering drawings, P&IDs (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• Track document revision history and ensure obsolete documents are withdrawn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
• Equipment & Facility Documentation
• P&ID & 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

Salary :- Upto 7.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-