Job Description
Purpose of the Role
To operate, maintain, calibrate, troubleshoot, and improve instrumentation and automation systems used in pharmaceutical manufacturing facilities, ensuring uninterrupted operations, regulatory compliance, data integrity, equipment reliability, and adherence to cGMP requirements.
Key Roles & Responsibilities
Instrumentation Maintenance
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Carry out preventive, predictive, breakdown, and corrective maintenance of instrumentation systems.
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Maintain field instruments including pressure gauges, transmitters, temperature sensors, RTDs, thermocouples, flow meters, level transmitters, control valves, VFDs, and analyzers.
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Ensure reliable functioning of manufacturing, utility, and packaging equipment instrumentation.
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Minimize equipment downtime through timely troubleshooting and repairs.
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Perform routine health checks of critical instruments.
Calibration Activities
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Perform calibration of instruments as per approved calibration schedules and SOPs.
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Execute calibration of pressure, temperature, flow, level, conductivity, humidity, and differential pressure instruments.
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Maintain calibration records and certificates.
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Ensure all instruments remain within specified accuracy limits.
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Identify and replace defective instruments when required.
Automation & Control Systems
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Monitor and maintain PLC, SCADA, HMI, BMS, EMS, and automation systems.
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Support troubleshooting of automated manufacturing and utility systems.
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Assist in PLC program backup, restoration, and modification activities under guidance.
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Ensure smooth operation of data acquisition and monitoring systems.
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Support serialization and automated packaging systems where applicable.
Utility System Support
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Maintain instrumentation associated with HVAC systems.
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Support instrumentation of purified water, WFI, compressed air, nitrogen, vacuum, and steam systems.
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Monitor critical utility parameters affecting manufacturing operations.
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Ensure proper functioning of environmental monitoring instruments.
Manufacturing Equipment Support
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Maintain instrumentation associated with Granulation, Compression, Coating, Capsule Filling, Blister Packing, and Bottle Packing equipment.
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Attend equipment breakdowns and restore operations within defined timelines.
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Support equipment commissioning, qualification, and validation activities.
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Ensure critical alarms and interlocks function properly.
Documentation & Compliance
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Maintain maintenance logbooks, calibration records, breakdown reports, and work orders.
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Follow Good Documentation Practices (GDP) and Data Integrity requirements.
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Document all maintenance activities accurately and contemporaneously.
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Update instrument history records and maintenance databases.
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Support audit and inspection documentation requirements.
Qualification & Validation Support
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Support IQ, OQ, PQ, DQ, FAT, and SAT activities for new equipment and systems.
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Participate in commissioning and qualification of instrumentation systems.
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Assist in validation of computerized and automated systems.
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Provide technical support for change controls and requalification activities.
cGMP & Regulatory Compliance
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Ensure compliance with cGMP requirements and engineering SOPs.
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Support readiness for USFDA, MHRA, WHO-GMP, EU-GMP, and other regulatory inspections.
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Participate in internal audits and regulatory inspections.
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Ensure all instrumentation activities are performed according to approved procedures.
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Adhere to ALCOA+ and Data Integrity requirements.
Safety, Health & Environment (EHS)
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Follow electrical and instrumentation safety procedures.
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Obtain necessary work permits before executing maintenance activities.
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Use appropriate PPE while performing maintenance work.
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Report unsafe conditions, incidents, and near misses.
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Participate in safety observations, risk assessments, and emergency drills.
Spare Parts & Inventory Management
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Maintain inventory of critical instrumentation spares.
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Raise requirements for calibration standards and spare parts.
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Monitor stock levels to avoid maintenance delays.
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Verify and inspect incoming instrumentation materials and components.
Continuous Improvement
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Participate in reliability improvement initiatives.
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Support energy conservation and automation projects.
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Identify opportunities to improve equipment uptime and process efficiency.
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Participate in Lean, TPM, Kaizen, and Operational Excellence initiatives.
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Recommend upgrades for obsolete instruments and control systems.
Team Coordination
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Coordinate with Production, QA, QC, Engineering, Validation, and Projects teams.
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Support external vendors during maintenance and qualification activities.
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Assist in training operators and technicians on instrumentation-related aspects.
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Ensure effective communication during shift handovers.
Qualifications
Educational Qualification
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B.Tech / B.E. in Instrumentation Engineering, Electronics & Instrumentation Engineering, Electrical & Electronics Engineering, Electronics Engineering, or related discipline.
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Diploma in Instrumentation/Electronics with relevant pharmaceutical experience may also be considered.
Experience
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6-10 years of experience in calibration, instrumentation, or engineering functions within pharmaceutical, biotechnology, API, vaccine, or regulated manufacturing industries.
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Experience in GMP-regulated environments and computerized calibration systems preferred.
