Maintenance Engineer

Quality HR India Pvt. Ltd.; Vapi; On-site; INR 630,000 - 770,000; Full time

Job summary

Quality HR India Pvt. Ltd. in Vapi is seeking a Maintenance Engineer with 2–5 years of experience in pharma API environments to manage documentation, equipment and facility records, and GMP compliance.

You will prepare IQ/OQ/PQ docs, maintain P&IDs, SOPs, CMMS entries, calibration logs, and support regulatory audits (FDA, EMA, WHO). Diploma/BE in mechanical or electrical is required. This hands-on role involves cross-functional coordination with QA, Validation and production teams, ensuring

Qualifications

• Experience in maintaining engineering drawings, P&IDs, equipment manuals and spare parts lists.
• Knowledge of IQ/OQ/PQ and validation processes.
• Familiar with cGMP (21 CFR Part 211) for API manufacturing.
• Experience with document control systems (DMS/EDMS) and audit support.

Responsibilities

• Maintain and control engineering drawings, P&IDs, equipment manuals, and spare parts lists.
• Create and update equipment files, asset registers, and technical specifications.
• Develop and maintain PM procedures and schedules.
• Write and revise SOPs for maintenance activities.
• Manage CMMS documentation and maintenance logs.
• Support regulatory audits with documentation.

Skills

Preventive Maintenance

Breakdown Maintenance

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

Education

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

Tools

CMMS

Veeva EDMS

Documentum

MasterControl

Job description

Position: Maintenance Engineer

Location: Vapi

Experience: 2 - 5Years

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