DD Enterprises
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ddentp.com
Job details:
JOB DESCRIPTION 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-safe 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 3yr – 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. Education Bachelor’s Degree in Instrumentation / Electrical / Automation / Chemical Engineering. Mn Exp : 3 Yrs- 8ys
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