: Senior Siemens PCS 7 / SIMATIC Batch Lead Engineer – Pharmaceutical Automation (8+ Years Experience)

Position Summary :

We are looking for a Senior Siemens Batch Automation Lead Engineer / SME with minimum 8 years of pharmaceutical automation project experience to lead complete lifecycle delivery of PCS 7 and SIMATIC Batch systems. This role requires technical ownership from design through commissioning, validation, client coordination, and post-go-live optimization.

Key Role Expectations:

- Lead batch architecture development including Process Cell, Unit, EM, CM, recipe philosophy, and exception handling.
- Own SIMATIC Batch master recipe design, library standardization, and reusable phase strategy.
- Configure FactoryTalk Batch recipes, Simatic Batch recipe operations, phases, and equipment models based on approved standards.
- Lead PCS 7, Plant Pax software development, code review, interlock philosophy, alarm rationalization, and fail-secure strategy.
- Review/approve FDS, SDS, HDS, IO list, cause-effect, FAT/SAT, IQ/OQ protocols.
- Lead FAT, SAT, commissioning, startup troubleshooting, and performance stabilization.
- Interface with QA, Validation, Client SMEs, MES vendors, and OEM packages.
- Mentor junior engineers and define coding/documentation standards.
- Drive deviation closure, CAPA actions, and audit observations.

Mandatory Skills:

- Minimum 3yrs – 8 yrs Siemens PCS 7/ Rockwell Plant Pax experience with SIMATIC Batch / FT Batch pharma projects.




- Minimum 2 to 3 end-to-end pharma batch project leadership experience.
- Strong understanding of GAMP5, 21 CFR Part 11, Annex 11, CSV lifecycle.
- Expertise in WinCC OS, historian integration, MES/LIMS interfaces, cybersecurity considerations. • Strong customer-facing and technical decision-making ability.
- Design, configure, and maintain Master Recipes, Library Operations, Unit Procedures, Operations, and Phases in Siemens SIMATIC Batch/ FT batch as per ISA-88 standards.
- Develop and configure Process Cells, Units, Equipment Modules, and Control Modules within Siemens PCS 7/ Rockwell Plant PAx batch hierarchy.
- Configure batch sequencing logic, parameter handling, material management, equipment arbitration, and exception handling.
- Program Siemens PCS 7/ Rockwell Plant Pax automation logic using CFC, SFC, SCL, and STL for pharmaceutical process skids and plant systems.
- Configure interlocks, permissive, alarms, sequence controls, phase logic, and fail-safe operational strategies.
- Develop reusable automation libraries and standardized faceplates for batch and continuous process applications. Develop operator graphics, faceplates, alarm views, trend displays, and navigation structures in WinCC / PCS 7 OS.
- Configure user management, audit trails, electronic signature prompts, and operator guidance screens.
- Support ISA-101 based HMI standardization initiatives.

Educational Qualification: Bachelor’s Degree in Instrumentation / Electrical / Automation / Chemical Engineering.

Minimum Exp: 3yrs- 8yrs

📌 Senior Engineer - Automation Software Engineering (Pune)
🏢 DDE Bioengineering
📍 Pune