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
