Csv Engineer
4 days ago
This role is responsible for supporting Identity and Access Management systems and other projects to qualify some IT systems.
**Responsibilities**:
- Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols.
- Responsible for providing CSV documents and protocols, performing execution for automated equipment and/or control systems, and closure of executed protocols.
- Provide guidance on test case execution and exception handling and system SOPs.
- Work with QA and program manager to ensure the project team understands GMP and validation requirements.
- Work with QA to provide guidance on the change request process.
- Work with QA doc to ensure team understand documentation requirement and doc change process.
- Support program manager on quality related topics
- Calls in Europe and UK timing are expected.
**About You**:
- Bachelor of Science/Engineering or higher in a scientific or related engineering discipline
- At least 3 - 6 years of experience in validation or computerized system validation
- Able to initiate and drive validation discussion.
- Experience with Kneat is optional because Kneat is quite easy to use
- Must be team player, curious with strong analytical and organizational skills
**Job Type**: Contract
Contract length: 9 months
Pay: $4,500.00 - $9,500.00 per month
**Experience**:
- CSV biotech facility: 5 years (preferred)
Work Location: In person
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