Software Automation Engineer

Sr. Engineer- Automation Software – Bio Process Location - PuneKey Responsibility Areas Achieve high standards of quality, safety, and compliance in automation software design and implementation Drive innovation and continuous improvement in automation platforms to enhance equipment reliability, scalability and customer value. Ensure project execution excellence by meeting deadlines, cost targets, and technical specifications. Ensure automation software complies with FDA 21 CFR Part 11, Annex 11, and other regulatory requirements. Design, program, and configure PLCs, HMIs, SCADA, and data acquisition systems for pharmaceutical equipment. Support the PMs during IFAT/CFAT point closure Support the QA in closing the pre-IFAT points Coordinate with customer stakeholders during design reviews, FAT, and site installationSkill Sets required :- Proficiency inPLC programming (Siemens, Rockwell or equivalent Expertise in HMI/SCADA configuration and development (WinCC, FactoryTalk, Ignition, or equivalent). Experience in developingstructured automation software (modular, reusable code, libraries). Strong knowledge of industrial communication protocols(EtherNet/IP, Profinet, Profibus, Modbus, OPC UA, etc.). Familiarity withIIoT, Industry 4.0 concepts, and cloud-based integration. Thorough understanding ofGAMP 5, GMP guidelines, and FDA 21 CFR Part 11 / EU Annex 11 compliance. Knowledge ofsoftware lifecycle documentation (URS, FDS, DDS, HDS, SDS). Hands-on experience in preparing and executingIQ, OQ, FAT, and SAT protocols. BE with 5-10 years expeirence in the Machine manufacturing industry or biotech / Bio process industry.Applicants with relevant experience from the bio process Industry can email their profiles to poornima.c@

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