We are seeking a skilled CSV Engineer to join our team in Australia. This individual will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution.
The ideal candidate will have a strong background in Computer Systems Validation (CSV) and GMP environments. They will be responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
Key Responsibilities:
* Prepares/reviews validation documentation related to projects/change controls.
* Manages change controls and other compliance related tasks.
* Participates in the review of current and future CSV procedures and policies.
* Analyses the results of testing and determines the acceptability of results against predetermined criteria.
Requirements:
* BS in a Computer Science or Engineering field or equivalent experience.
* Minimum 2-7 years' experience with Computer systems validation.
* Minimum 2-7 years' experience working in a GMP environment.
Benefits:
* Highly competitive salary.
* Continuing education (internal and external).
* Opportunities to work on cutting-edge projects in a highly evolving field.
We offer a dynamic work environment and opportunities for professional growth. If you are a motivated and experienced CSV Engineer looking for a new challenge, please apply.
We are an equal opportunity employer and welcome applications from qualified candidates.