What you need to know
You will work as a Software Validation Engineer for our client, an established Medical Device company in the Southeast.
This is a permanent position.
Your new job
Key duties & responsibilities:
- Responsible for preparing computer software validation protocols, test scripts and reports.
- Responsible for evaluating changes to validated/qualified Systems
- Responsible for software deviations and non-conformances
- Ensure review of all software related GMP critical documents
- Partake in software corrective action process and CAPA plans.
- Review of pre-delivery or vendor-supplied information with regards to suitability to proceed with validation activities.
- Travel to vendor locations for project reviews will be required.
- Provide technical expertise in the validation of new technologies to ensure they meet the Safety, Quality and Operational requirements.
- Lead and participate in risk management activities e.g. FMEAs.
What are we looking for?
- Qualified to degree level in Engineering or computing discipline
- 3-5 years’ experience in a computer system validations role.
- Working knowledge of statistical analysis and machine vision fundamentals would be a plus.
- Experience with vendor equipment builds, process automation, machine vision systems and medical products desirable.
- Knowledge of latest regulatory/industry standard approaches to Data Integrity.
Apply for this job now by sending your CV to John.
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