Saasvaap - Validation Engineer - CSV/PLC

As a CSV/PLC Validation Engineer, you will be a critical part of our validation team, ensuring that our systems meet the highest standards of quality and compliance. You will work closely with clients and internal teams to develop and implement validation strategies, conduct risk assessments, and ensure adherence to regulatory requirements. Your expertise will be instrumental in maintaining the integrity and reliability of our PLC-based systems. Responsibilities : - Develop and execute validation protocols (IQ, OQ, PQ) to ensure compliance with regulatory requirements. - Design and implement test scripts and procedures for PLC-based complex systems. - Conduct thorough testing and document test results. - Prepare comprehensive validation documentation, including Validation Master Plans (VMP), Risk Assessments, Functional Specifications (FS), Configuration Specifications (CS), Functional Requirements Assessments (FRA), and 21 CFR Part 11 Assessments. - Ensure all documentation is accurate, complete, and compliant with regulatory guidelines. - Ensure adherence to 21 CFR Part 11, EU Annex 11, cGMP, GAMP5, and Data Integrity regulations. - Stay up-to-date with the latest regulatory requirements and industry best practices. - Conduct gap analyses and implement corrective actions to ensure compliance. - Collaborate with clients to develop validation strategies and plans. - Conduct risk assessments and change control activities in collaboration with clients. - Provide training and support to clients on validation principles and procedures. - Perform Computer System Validation (CSV) for PLC-based complex systems. - Validate Building Management Systems (BMS), Distributed Control Systems (DCS), and Lab & Vision Software. - Ensure data integrity and system reliability. Required Skills : Experience : - 4-6 years of hands-on experience in Computer System Validation (CSV) for PLC-based systems. - Strong understanding of PLC-based systems and their validation requirements. - Knowledge of BMS, DCS, Lab & Vision Software Validation. - Proficiency in developing and executing validation protocols (IQ, OQ, PQ). - Experience in preparing validation documentation (VMP, Risk Assessment, FS, CS, FRA, test scripts, 21 CFR Part 11 Assessment). - Strong understanding of GxP, GMP, validation testing, and regulatory guidelines (21 CFR Part 11, EU Annex 11, cGMP, GAMP5, Data Integrity). Soft Skills : - Excellent documentation, communication, and stakeholder management skills. - Strong problem-solving and analytical skills. - Ability to work independently and remotely. - Detail-oriented and committed to quality. (ref:hirist.tech)

Location: ernakulam, IN

Posted Date: 5/7/2025