Job Title: Lab IT CSV Engineer – Cork site based (JO916)
Job Desc: Zenith Technologies are looking for a Computer Systems Validation Engineer to join the Computer System Validation Team on a long term basis in Cork.
Location: Cork, Ireland
The Computer System Validation team provides Computer System Validation support to the Quality Control Laboratories and production facilities of a large multi-national Pharmaceutical manufacturing facility in Cork.
Zenith maintain a Managed Service on the site, supporting Automation, MES, IT functions across operational and project levels. We are seeking an enthusiastic and experienced computer system validation engineer to join the team on a long-term basis. The Computer System Validation Engineer will provide IT systems validation and compliance expertise for newly purchased instruments and support of existing instruments as well as maintaining all Lab based Systems on-site.
Qualifications, Experience / Skills:
- 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.
Main Responsibilities / Duties:
• 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
*Further details on role available to short listed candidates.
Apply through this link or send your CV referencing job order – JO916 to Jillian.Barry@zenithtechnologies.com or call Jillian Barry in confidence +353 21 4370279. You can also link in https://ie.linkedin.com/in/jillianbarry1
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