Job Description

Department Details

Role Summary

Project-Instrumentation & Engineering

Key Responsibilities

ROLE SUMMARY:

• Conceptualization, Design and Execution of Projects
• Shall be accountable for design and Installation of PLC/DCS, SCADA, Bus Communication, Historian, and regular upgrades
• Hands on Experience in Preparing / estimations in Process Automation, Process Safety, automation, SCADA, PLC\'s.
• Good knowledge of Process Automation System
• Ability to understand projects specifications / requirements.
• Able to read and understand - P&IDs, PFDs, Operation methodology
• Shall be accountable for maintenance support during the installation and troubleshooting of process equipment, qualifying, and maintaining PLC driven equipment, BMS/EMS/, instrumentation in facility and utilities.

ROLE RESPONSIBILITIES:

Equipment Qualification:

• Ensure adequate support in qualifying of equipment.
• Review new concepts, communicate with vendors for new requirements and preparation and review of URS for new equipment.
• Coordination of any additional activities with Cross functional teams
• Review and approve qualification protocols.
• Review and approval of engineering drawings and layouts

Project management:

• Handling of new/expansion/improvement projects
• To identify continuous improvement initiatives (process improvement, energy efficiency, etc.)
• Ensure implementation of identified initiatives.

People Management:

• Know the processes and procedures, including the principles and practices of good data management (ALCOA).
• Be accountable for the good data management and data integrity understanding and performance of the team.

Documentation/Compliance:

• Develop procedures to comply with guidelines.
• Review and approval of GMP / quality documents & procedures
• Implement cGMP and ensure compliance with laid down SOPs, quality systems, safety systems at all stages of activity

Core Competencies:

• Knowledge of installation and troubleshooting of electronic and instrumentation systems in facility and utilities
• Experience in implementing and standardization procedures and processes.
• Expertise in electronic and instrumentation related activities in the facility and utilities
• Knowledge of installation, operation, and maintenance of electronic and instrumentation in facility and utilities
• Conversant with validation documents and protocols execution per schedule
• Knowledge on maintaining backup and restore procedures and tools for automated equipment.
• Detailed knowledge of preventive maintenance schedules / task lists, SOP\'s, and various audit procedures
• Knowledge on 21CFR part 11 compliance
• Knowledge on regulatory requirements
• Knowledge on computer system validation and preparation of documents

Standards, Processes & Policies

• cGMP and GDP in pharmaceutical Industry
• Knowledge on clean room requirements and regulatory guidelines
• Knowledge on metrological standards
• Good, automated manufacturing practice guidelines (GAMP) for validation of automated systems.

Educational Qualifications

Required Education Qualification: B.E
Required Experience: 10 - 15 years

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