Senior Engineer - Automation Software Engineering
DDE Bioengineering Pvt. Ltd.
Job Description
JOB DESCRIPTION Senior Siemens PCS 7 / SIMATIC Batch Lead Engineer β 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 β’ Lead batch architecture development including Process Cell, Unit, EM, CM, recipe philosophy, and exception handling. β’ Own SIMATIC Batch master recipe design, library standardization, and reusable phase strategy. β’ Configure FactoryTalk Batch recipes, Simatic Batch recipe operations, phases, and equipment models based on approved standards. β’ Lead PCS 7, Plant Pax software development, code review, interlock philosophy, alarm rationalization, and fail-safe strategy. β’ Review/approve FDS, SDS, HDS, IO list, cause-effect, FAT/SAT, IQ/OQ protocols. β’ Lead FAT, SAT, commissioning, startup troubleshooting, and performance stabilization. β’ Interface with QA, Validation, Client SMEs, MES vendors, and OEM packages. β’ Mentor junior engineers and define coding/documentation standards. β’ Drive deviation closure, CAPA actions, and audit observations.
Mandatory Skills β’ Minimum 3yr β 8 yrs Siemens PCS 7/ Rockwell Plant Pax experience with SIMATIC Batch / Ft Batch pharma projects. β’ Minimum 2 to 3 end-to-end pharma batch project leadership experience. β’ Strong understanding of GAMP5, 21 CFR Part 11, Annex 11, CSV lifecycle. β’ Expertise in WinCC OS, historian integration, MES/LIMS interfaces, cybersecurity considerations. β’ Strong customer-facing and technical decision-making ability. β’ Design, configure, and maintain Master Recipes, Library Operations, Unit Procedures, Operations, and Phases in Siemens SIMATIC Batch/ FT batch as per ISA-88 standards. β’ Develop and configure Process Cells, Units, Equipment Modules, and Control Modules within Siemens PCS 7/ Rockwell Plant PAx batch hierarchy. β’ Configure batch sequencing logic, parameter handling, material management, equipment arbitration, and exception handling. β’ Program Siemens PCS 7/ Rockwell Plant Pax automation logic using CFC, SFC, SCL, and STL for pharmaceutical process skids and plant systems. β’ Configure interlocks, permissive, alarms, sequence controls, phase logic, and fail-safe operational strategies. β’ 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. β’ Configure user management, audit trails, electronic signature prompts, and operator guidance screens. β’ Support ISA-101 based HMI standardization initiatives. Education Bachelorβs Degree in Instrumentation / Electrical / Automation / Chemical Engineering.
Mn Exp : 3 Yrs- 8ys