CSV Engineering Expert

1 week ago


Singapore beBeeEngineering Full time $100,000 - $120,000
Job Overview

In this pivotal role, you will oversee the Computer System Validation Lifecycle, driving it from design to execution phases. This entails creating and maintaining relevant CSV documentation such as configuration specifications, design reviews, commissioning documents, and protocols.

About the Position
We are seeking a highly skilled professional with extensive experience in DeltaV coding and configuration. The ideal candidate will have a solid grasp of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), as well as knowledge of Health Authorities standards such as FDA CFR and EU regulations.

Main Responsibilities
* Manage the Computer System Validation Lifecycle from design to execution phases
* Develop and maintain relevant CSV documentation
* Collaborate with QA and stakeholders to develop the CSV strategy
* Execute test cases, handle deviations, and draft system SOPs
* Additional tasks assigned by Supervisor/Manager

Essential Requirements
* Bachelor Degree in a scientific or related engineering discipline with at least 5 years' experience in CSV QA validation
* Strong understanding of DeltaV coding and configuration
* Knowledge of validation lifecycle, cGMP, and GDP
* Familiarity with Health Authorities standards such as FDA CFR and EU
* Proven teamwork skills with strong analytical and organizational abilities

Desirable Qualifications
* Experience with Emerson DeltaV
* Excellent analytical and problem-solving skills
* Outstanding communication and interpersonal skills
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