Software Automation Engineer

1 week ago

Pune, Maharashtra, India Classic Search Private Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Sr. Engineer- Automation Software – Bio Process

Location - Pune

Key Responsibility Areas

  1. Achieve high standards of quality, safety, and compliance in automation software design and implementation
  2. Drive innovation and continuous improvement in automation platforms to enhance equipment reliability, scalability and customer value.
  3. Ensure project execution excellence by meeting deadlines, cost targets, and technical specifications.
  4. Ensure automation software complies with FDA 21 CFR Part 11, Annex 11, and other regulatory requirements.
  5. Design, program, and configure PLCs, HMIs, SCADA, and data acquisition systems for pharmaceutical equipment.
  6. Support the PMs during IFAT/CFAT point closure
  7. Support the QA in closing the pre-IFAT points
  8. Coordinate with customer stakeholders during design reviews, FAT, and site installation

Skill Sets required :-

  1. Proficiency in
    PLC programming (Siemens, Rockwell or equivalent
  2. Expertise in HMI/SCADA configuration and development (WinCC, FactoryTalk, Ignition, or equivalent).
  3. Experience in developing
    structured automation software (modular, reusable code, libraries).
  4. Strong knowledge of industrial communication protocols
    (EtherNet/IP, Profinet, Profibus, Modbus, OPC UA, etc.).
  5. Familiarity with
    IIoT, Industry 4.0 concepts, and cloud-based integration.
  6. Thorough understanding of
    GAMP 5, GMP guidelines, and FDA 21 CFR Part 11 / EU Annex 11 compliance.
  7. Knowledge of
    software lifecycle documentation (URS, FDS, DDS, HDS, SDS).
  8. Hands-on experience in preparing and executing
    IQ, OQ, FAT, and SAT protocols.
  9. 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

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