πŸ• Posted 4d ago

Senior Engineer - Automation Software Engineering

DDE Bioengineering Pvt. Ltd.

Pimpri ChinchwadFull-timeMid LevelOn-site

Job Description

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 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 – 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 Bachelor’s Degree in Instrumentation / Electrical / Automation / Chemical Engineering.

Mn Exp : 3 Yrs- 8ys

Posted 4 days ago

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