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CSV Audit trails

1 month ago

Cork, Cork, Ireland Cognizant Full time
Computerised Systems Engineer

Zenith Technologies, now a Cognizant Company, is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures, and services.

Job Summary

The Lab Computer System Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. We are seeking an enthusiastic and experienced Lab CSV Engineer to join our team on a long-term contract basis. The Lab CSV Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments. The position will work within a collaborative Computerised Instruments team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative. Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

Desired Background/Experience/Attributes:

1. Minimum 10 years' experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting.
2. Experience of analyzing and challenging software to identify gaps.
3. Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable.
4. Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
5. Self-motivated, detail-oriented, and excellent organizational and time management skills.
6. Capable of relating well to other people with whom s/he comes in contact, both within and outside of the laboratory area.

Role will involve:

1. Manage lab equipment validation projects from software install to business release.
2. Prioritize CSV activities in line with the project schedule and monitor budgets.
3. Generate computer system validation documentation, e.g. Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines.
4. Review of software release notes.
5. Liaise with service providers to determine successful installation of instrument software and ensure correct configuration.
6. Determine any specific configurations for the software, e.g. how data is saved and named.
7. Understand and define user permissions.
8. Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria.
9. Work with the business to identify and implement procedural controls to mitigate issues found during testing.
10. Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
11. Determine solutions or recommendations for changes and/or improvements.
12. Produce documentation that is well written and consistent throughout the document body e.g. headings, font type, font size, paragraph spacing, text alignment, correct tense.
13. Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required.

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