Senior Validation Engineer
2 days ago
**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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