Responsibilities :
- years' Experience in Validating MES or Manufacturing an Lab systems.
- Experienced in CSV activities in Manufacturing related applications like SAP Systems, MES systems or Lab related systems in the manufacturing space.
- Perform review for GxP systems to ensure compliance with regulatory requirements.
- Working knowledge on end-to-end validation of GxP applications and is able to perform document / process Compliance Analysis.
- Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology.
- Reviews - Requirement Specifications, Functional Specifications / User Stories / Acceptance Criteria and ensures completeness of test script with traceability.
- Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements.
- Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement.
- Ensures pre-executed test protocol has the necessary test data requirements to run the tests.
- Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process.
- Able to author Validation Plan and compile Validation Summary Report and generates RTM.
- Reviews and ensures that the Operational Procedure for the application is ready.
- Is able to handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan / Results, Defects and RTM.
Lead CSV Engineer/Analyst - 5072
Lead CSV Engineer/Analyst Responsibilities:. Perform CSV for production equipment and analytical instruments. Collaborate with engineering and CQV teams to align automation validation activities with project timelines. Oversee documentation lifecycle for CSV activities, ensuring compliance with regu...
CSV Validation Engineer
Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements. ...
CSV Validation Engineer
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the result...
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CSV Engineer
Experienced in CSV activities in Manufacturing related applications like SAP Systems, MES systems or Lab related systems in the manufacturing space. ...
Lead CSV Engineer/Analyst - 5072
Lead CSV Engineer/Analyst Responsibilities:. Perform CSV for production equipment and analytical instruments. Collaborate with engineering and CQV teams to align automation validation activities with project timelines. Oversee documentation lifecycle for CSV activities, ensuring compliance with regu...
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On-Board Administrative is hiring a CSV Engineer . The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites through interaction with internal customers and external service providers. Ability to follow oral and wri...
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Sr. CSV Engineer, Trackwise
As a Computer Systems Validation (CSV) Consultant you will:. ...
Sr. CSV Engineer, Trackwise
As a Computer Systems Validation (CSV) Consultant you will:. ...