Software Automation Engineer

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