Senior Validation Engineer

2 days ago


Pune, Maharashtra, India KARYA CONSULTANTS PRIVATE LIMITED Full time

**Job Title:** Senior Validation Engineer - Regulatory Compliance Expert

**Job Summary:

We are seeking a highly skilled Senior Validation Engineer to join our team at KARYA CONSULTANTS PRIVATE LIMITED. As a key member of our team, you will be responsible for ensuring compliance with strict regulatory standards in various industries such as pharmaceuticals, biotechnology, medical devices, automotive, or manufacturing.

**Key Responsibilities:**

  • Develop and implement validation plans, protocols, and procedures to ensure alignment with project specifications and regulatory requirements.
  • Validate applications using SCADA/PLC systems, focusing on functionalities, performance, and compliance.
  • Collect, analyze, and report validation test data to support quality and operational safety.
  • Collaborate with teams like Quality Assurance, Engineering, and Production to ensure alignment of validation activities.

**Required Skills and Qualifications:**

  • Bachelors degree in Engineering, Computer Science, Information Systems, or related fields.
  • Certification in Validation Engineering or Quality Management is a plus.
  • 3-4 years of experience in Validation Engineering, with a focus on software validation, PLC/SCADA systems, and regulatory compliance.

**Regulatory Knowledge and Technical Skills:**

  • Familiarity with FDA 21 CFR Part 11, GxP, and Good Documentation Practices (GDP).
  • Understanding of ISO standards and Good Automated Manufacturing Practices (GAMP).
  • Proficiency in validating and managing SCADA (Supervisory Control and Data Acquisition) and PLC (Programmable Logic Controller) systems.

**Salary:** The estimated salary for this position is ₹ 800000 per year, depending on the candidate's qualifications and experience.

**Benefits and Other Requirements:**

  • Strong understanding of validation processes for Computer Systems (CSV) and PLC/SCADA systems.
  • Ability to read and understand wiring and ladder logic diagrams for PLC/SCADA systems.


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