CSV Engineer (Pharma/Biotech) (NPC-10081) - Part-Time

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