VAPI · FULLTIME
Maintenance Engineer
Quality HR Services
Vapi · onsite · Posted 27d ago
Sourced from
Undisclosed2–5 yrsfulltimeVapi
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Section · 01
About this role
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- Track document revision history and ensure obsolete documents are withdrawn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
- 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
Diploma/B.E/B.Tech - Mechanical/Electrical
Key Skills - Sop
- Gmp
- Documentation
- Regulatory Compliance
Sourced from naukri
Section · 02
Skills
InstrumentationBreakdown MaintenanceDocument ManagementAPI ManufacturingCGMPCfrcontrol engineeringGaugesauditsDocumentumCSVCAPAChange ControlehsEngineering DrawingsEquipment QualificationHVACcomplianceCMMS
Section · Company
About Quality HR Services
Quality HR Services
Recruitment
30
employees
2017
9 years old
Vapi, Gujarat
India
₹3.1L PA avg
Avg at Quality HR Services
About
Quality HR Services
Industries
Recruitment
Employee ratings
10 reviews
4.9/ 5
Culture
4.7
Career growth
4.6
Work-life
4.8
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Company Culture49Overall Company49
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