CSV (Computer Validation Tester/ Engineer)

BE degree or equivalent work experience in Computer Science, Biology, Biomedical or related field.

7+ years of Computer System Validation/ Product Software Validation testing experience in a regulated environment.

Understanding of US FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and ISO regulations. e.g., design controls, risk management, and software validation.

Self-motivated, willing to learn new concepts, technologies, and products quickly.

Excellent interpersonal, writing and communication skills, and troubleshooting skills.

Passionate about testing, product quality, and customer satisfaction.

It would be a plus if you also possess previous experience in:

Software development life cycle (SDLC) methodologies (e.g., Waterfall, Agile) and experience working with different system types such as Product Software, Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), or Enterprise Resource Planning (ERP) systems.

Implemented and transformed the process from CSV to CSA.

Involved in implementing AI/ML and Cloud solutions.