Senior Automation Software Engineer

Classic Search Private LimitedPune, Republic Of India, IN

3 days ago

Job description

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 : -

Proficiency 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.

Applicants with relevant experience from the bio process Industry can email their profiles to poornima.c@classicsearchplc.com

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Senior Engineer Automation • Pune, Republic Of India, IN

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