Maintenance Engineer

Opening: 1 Nos.
Job ID: 148879
Employment Type: Full Time
Reference:
Work Experience: 2.0 Year(s) To 5.0 Year(s)
CTC Salary: 5.00 LPA TO 7.00 LPA
Function: Production / Quality / Maintenance
Industry: Pharma/Biotech/Clinical Research
Qualification: B.Tech/B.E. - Electrical; B.Tech/B.E. - Mechanical; Diploma - Electrical; Diploma - Mechanical
Location: Vapi
Posted On: 17th Sep, 2026

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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- Track document revision history and ensure obsolete documents are withdrawn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 in this opening, please send an updated resume with the following details:

- Total No. of Years Experience:
- Current CTC:
- Expected CTC:
- Notice Period:

Key Skills:

- SOP
- GMP
- Documentation
- Regulatory Compliance

Company Profile

It is specializing in Active Pharmaceutical Ingredients.

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