GXP Validation Engineer
3 months ago
Key Responsibilities :
- Develop and implement validation plans, protocols, and procedures.
- Ensure validation strategies align with project specifications and regulatory requirements.
- Draft and review validation protocols (IQ/OQ/PQ) and ensure they meet industry standards and regulatory guidelines.
- Validate applications using SCADA/PLC systems, focusing on functionalities, performance, and compliance.
- Collect, analyze, and report validation test data.
- Maintain thorough documentation, including validation protocols and summary reports.
- Ensure compliance with regulations such as GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO standards.
- Collaborate with teams like Quality Assurance, Engineering, and Production to ensure alignment of validation activities.
- Identify process improvement opportunities in validation activities.
- Propose and implement Corrective and Preventive Actions (CAPA).
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.
- Experience with System Development Life Cycle (SDLC) and GAMP 5 guidelines.
Regulatory Knowledge :
- Familiarity with FDA 21 CFR Part 11, GxP, and Good Documentation Practices (GDP).
- Understanding of ISO standards and Good Automated Manufacturing Practices (GAMP).
Technical Skills (Software-Related) :
- Proficiency in validating and managing SCADA (Supervisory Control and Data Acquisition) and PLC (Programmable Logic Controller) systems.
- Experience in SQL to handle database validation and support data queries for validation purposes.
- Familiarity with tools for automated testing and validation within SCADA/PLC environments.
- Experience with software like HP ALM, JIRA, or other similar tools for managing validation tasks, defect tracking, and reporting.
- Understanding of ladder logic diagrams and ability to download and modify PLC/HMI application programs.
- Familiarity with tools for ensuring compliance with 21 CFR Part 11 and other regulatory standards.
Other Skills :
- 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.
- Experience with SQL for database validation and querying.
- Proficiency with test management tools for logging and tracking defects during validation (e.g., HP ALM, JIRA, or other similar tools).
- Experience preparing and executing documents such as GAP analysis, IRA, FRA, FDS, FMEA, SRS, and Validation Summary Reports (VSR).
This role primarily applies in industries such as pharmaceuticals, biotechnology, medical devices, automotive, or manufacturing, where ensuring compliance with strict regulatory standards is crucial for quality and operational safety.
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