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Profisolutions is seeking an experienced Automation Engineer with strong Siemens PCS 7 DCS and TIA Portal expertise for pharma process automation. The role covers design, configuration, validation, commissioning, and lifecycle support in GMP environments, with focus on CFR 11 and EU Annex 11.
You'll work on PCS 7, WinCC, and PLC programming, collaborating with QA and Validation teams, with travel to client sites. Excellent knowledge of CSV, GAMP 5, and regulatory audits is essential.
Bengaluru / Client Sites (as applicable)
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.
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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.
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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).
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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).
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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.
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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
BE / BTech / Diploma in:
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Instrumentation
Electrical
Electronics
Automation Engineering
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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