Automation Engineer Siemens PCS 7 & TIA Portal

Location

Bengaluru / Client Sites (as applicable)

Job Summary

We are looking for a skilled Automation Engineer with strong experience in Siemens

PCS 7 DCS and TIA Portal, specically within pharmaceutical manufacturing environments. The role involves development, validation, commissioning, and lifecycle support of automation systems while ensuring compliance with GMP, GAMP 5, and 21

CFR Part 11 requirements.

Key Responsibilities

Automation Engineering (Pharma Focus)

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Design, congure, and maintain Siemens PCS 7 DCS systems for pharma processes such as:

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Weighing & dispensing

Granulation

Tablet compression

Coating

Clean utilities (PW, WFI, Pure Steam)

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Develop PLC logic using TIA Portal (S7-1200 / S7-1500).

Congure PCS 7 CFC/SFC, phases, sequences, and interlocks aligned with pharma process workows.

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Develop and maintain WinCC SCADA / HMI screens with pharma-compliant alarm management.

Validation & Compliance

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Participate in CSV (Computer System Validation) activities in compliance with:

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GAMP 5

21 CFR Part 11

EU GMP Annex 11

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Prepare and execute validation documents:

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URS, FS/FDS, HDS, SDS

IQ, OQ, PQ

Traceability Matrix (TM)

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Congure Audit Trails, User Management, Electronic Signatures, and security policies.

Support audits from regulatory authorities (USFDA, MHRA, WHO).

System Integration

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Interface automation systems with

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Process equipment skids

Clean utility systems

Weighing systems

MES / Historian systems

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Congure communication via Pronet, Probus, Modbus, OPC.





Integration with Batch systems (PCS 7 Batch / ISA-88 concepts).

Testing, Commissioning & Support

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Perform FAT, SAT, loop checking, and commissioning at plant sites.

Troubleshoot and optimize existing PCS 7 / PLC systems during production.

Support change control, deviation handling, and periodic reviews.

Mandatory Skills

Technical Skills

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Siemens PCS 7 (v8.x / v9.x) Pharma application experience mandatory

TIA Portal (V15 and above)

Siemens PLCs: S7-300 / S7-400 / S7-1500

WinCC (Classic / Skilled)

Industrial protocols: Pronet, Probus

Alarm management and recipe handling

Pharma & Regulatory Knowledge

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GMP manufacturing processes

GAMP 5 lifecycle approach

21 CFR Part 11 compliance

Data integrity principles (ALCOA+)

Preferred / Added Advantage

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Experience with

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PCS 7 Batch

Siemens Opcenter / MES integration

Clean room automation

SIS / Failsafe systems

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Automation system migration in pharma plants

Exposure to cybersecurity in regulated environments

Soft Skills

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Strong documentation and validation mindset

Ability to work in regulated, audit-driven environments

Eective coordination with QA, Process, and Validation teams

Willingness to travel to pharma client sites

Education

BE / BTech / Diploma in:

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Instrumentation

Electrical

Electronics

Automation Engineering

What We Oer

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Opportunity to work on regulated, high-value pharma projects

Exposure to global validation standards

Long-term career growth in Life Sciences Automation

Competitive compensation and learning opportunities

📌 Plc Programmer (Chennai)
🏢 Profisolutions
📍 Chennai