Company Overview
Role Purpose
Manager - Instrumentation and Automation
Academic Stream
B.E. / B.Tech (Instrumentation)
Work experience (in months)
14 to 18 years
Job Responsibility and key Decisions
Key Responsibilities
1. Automation System Leadership
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Lead and manage Siemens/Rockwell-based automation systems.
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Oversee Siemens PLC platforms (TIA Portal, SIMATIC Manager).
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Manage PCS7 systems, including batch processing aligned with ISA‑88 standards.
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Design and maintain automation architecture for process and utility systems.
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Ensure high system availability and reliability for manufacturing operations.
2. Process System Expertise – Upstream & Downstream
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Provide technical oversight for automation in biopharmaceutical processes.
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Upstream Systems: Bioreactors and associated process control/monitoring systems.
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Downstream Systems: Centrifuges, chromatography systems, filtration units, buffer preparation systems.
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Utility & Support Systems: Purified water (PW), water-for-injection (WFI), building management systems (BMS), environmental monitoring systems (EMS), clean utilities integration.
3. Regulatory & Compliance
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Ensure compliance with 21 CFR Part 11, GAMP5, and data integrity requirements.
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Support internal and external audits (USFDA, MHRA, EU GMP, etc.).
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Review and approve validation documentation (URS, FS, DS, FAT, SAT, IQ, OQ).
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Maintain systems that meet global regulatory expectations.
4. Instrumentation & Controls
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Possess strong knowledge of field instrumentation and calibration practices.
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Manage control valves, sensors, transmitters, and VFD systems.
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Implement preventive and predictive maintenance strategies.
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Support troubleshooting and root cause investigations to minimize downtime.
5. Project & Upgrade Management
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Lead automation upgrade projects and system lifecycle management.
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Plan and execute migration activities from legacy to upgraded platforms.
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Coordinate with cross-functional teams (Manufacturing, QA, CSV, Projects).
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Drive digitalization initiatives and continuous improvement programs.
6. Team & Stakeholder Management
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Lead and mentor automation engineers and technicians.
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Coordinate with OEMs and system integrators for project execution and support.
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Act as Subject Matter Expert (SME) during regulatory audits.
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Ensure documentation accuracy and SOP adherence across automation activities.