System Validation Engineer Jobs

Requirements:

·Bachelor Degree in Computer Science, Information Technology, Software Engineering or equivalent

·At least one year experience in the same position

·Familiarity with 21 CFR 11 and Annex 11 and Data Integrity

·Have knowledge in the Serialization System, Track Wise System, LIMS system and Computer System Validation

·Willing to be placed at Cikarang

s:

·Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met

·Evaluate proposed changes to validated computer systems and recommend level of validation activities required

·Identify and qualify all computer systems which impact cGMP operations using a risk based methodology

·Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan

·Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans

·Execution of validation plans and validation documents

·Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.

·Work closely with Engineering Senior Manager, QA compliance & QA Validation to ensure appropriate validation of cGMP computer systems