The Computer System Validation team provides Computer System Validation support to the Quality Control Laboratories and production facilities of a large multi-national Biotech manufacturing facility in Cork.
Computer System Validation Engineer Cork JO1084
Zenith Technologies is a world leading provider of products and services to the Life Science industry. We are focused on improving our customers’ performance across the manufacturing enterprise through the application of innovative technologies. Zenith Technologies is embedded in numerous world leading Life Science multinational companies where we continue to deliver superior solutions.
We’re looking for dedicated, innovative and driven talent to join our expanding team.
“Innovation and change, Join ZT”
About the Role
The Computer System Validation team provides Computer System Validation support to the Quality Control Laboratories and production facilities of a large multi-national Biotech manufacturing facility in Cork. We are seeking an enthusiastic and experienced computer system validation engineer to join the CSV team on a long-term contract basis. The Computer System Validation Engineer will provide IT systems validation and compliance expertise for newly purchased instruments and support of existing instruments.
In line with the job outlined above, the following are typically the key tasks that would be expected of the role:
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Prioritize validation activities in line with the project schedule
- Update existing validation documentation including SOPs, Design Specs, configuration specs
- Execute ER/ES and Security test scripts
- Analyze the results of testing and determine the acceptability of results against pre-determined criteria
- Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements
- Initiate and implement Change Control activities in accordance with Quality Standards and Practices
- Interact with vendors / Service Providers to ensure the correct configuration and successful installation of the instrument software.
- Follow all relevant Quality, Health and Safety procedures and assist in incident investigations as required
- Recognise the importance of the quality control function in pharmaceutical production and display a high level of integrity in the performance of his/her work
- Minimum 3-5 years’ experience validating IT applications e.g. requirements gathering, design documentation, test case development, system & acceptance testing
- Past proven experience engaging business users to ensure that appropriate business needs are clearly defined, communicated and delivered at or above expectations
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
- Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
- Experience working in a Win 7 environment is an advantage
- S/he is expected to be self-motivated and develop an understanding of the business.
- Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.