Software Automation Engineer
ConfidentialPune, India10 hours ago
Job descriptionProficiency in PLC programming (Siemens, Rockwell or equivalent Expertise in HMI / SCADA configuration and development (WinCC, FactoryTalk, Ignition, or equivalent). Experience in developing structured automation software (modular, reusable code, libraries). Strong knowledge of industrial communication protocols (EtherNet / IP, Profinet, Profibus, Modbus, OPC UA, etc.). Familiarity with IIoT, Industry 4.0 concepts, and cloud-based integration. Thorough understanding of GAMP 5, GMP guidelines, and FDA 21 CFR Part 11 / EU Annex 11 compliance. Knowledge of software lifecycle documentation (URS, FDS, DDS, HDS, SDS). Hands-on experience in preparing and executing IQ, OQ, FAT, and SAT protocols. BE with 5-10 years expeirence in the Machine manufacturing industry or biotech / Bio process industry.
Sr. Engineer- Automation Software – Bio Process
Location - Pune
Key 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 installation
Skill Sets required : -
Applicants with relevant experience from the bio process Industry can email their profiles to [HIDDEN TEXT]
Skills Required
IIoT Industry 4.0 concepts and cloud-based integration, GAMP 5 GMP guidelines and FDA 21 CFR Part 11 EU Annex 11 compliance
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Automation Engineer • Pune, India
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