Responsibilities:
- Lead CSV activities for Computer Systems e.g. DeltaV, BAS, PLCs, MES and related mini-projects.
- 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 preparation of CSV documents and protocols, perform execution for automated equipment and/or control systems, and closure of executed protocols.
- Work largely requires use of valgenesis software to create validation documents and electronic test case execution.
- Work with SME to generate test cases and CSV documents.
- Provide guidance on test case execution and exception handling.
- Support SME on documentation matters and ensure documents are completed in time.
- Any other task as assigned by Supervisor/Manager.
About You:
- Bachelor of Science/Engineering or higher in a scientific or engineering discipline
- Proven senior-level experience in biotech validation work
- A track record of independently planning, executing, and closing CSV activities
- Able to work independently with not much supervision
- Strong autonomy in generating lifecycle documentations, test plan/cases, managing exceptions, and completing deliverables.
- Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams
- Must be team player, curious with strong analytical and organizational skills
- Strong ownership
Duration: 9 months. Option to extend/convert subject to performance review.
