Aegis Technology Solutions 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. ATS is embedded in numerous world leading Life Science multinational companies where we continue to deliver superior solutions.
One of our leading client in US, is looking for a senior CSV engineer to support the manufacturing facility in New York region.
The Senior Computer Systems Validation team is responsible for Computer System Validation of PC Controlled Instruments in the Quality Control Laboratories and production facilities of a large multi-national Biotech manufacturing facility in New York. We are seeking an experienced and enthusiastic Computer System Validation Engineer to join our growing 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 as well as maintaining all Lab based Systems on-site.
- Lead and coordinate IT & CSV activities on lab validation projects with multifunctional project teams, ensuring csv objectives are clear and understood and can be completed as efficiently as possible and on time
- Mentor junior members of the CSV team around data integrity and Computer System Quality standards and practices
- Prioritize validation activities in line with the project schedule
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Update existing validation documentation including SOPs, Design Specs, configuration specs
- Interact with vendors / Service Providers to ensure successful installation of the instrument software and correct configuration
- Execute Electronic Record and Electronic Signature test scripts and perform configuration verification
- 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
- 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 4-6 years’ experience validating IT applications e.g. requirements gathering, design documentation, test case development, system & acceptance testing
- IT qualification would be an advantage but not required
- 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
- Experience of server and workstation platforms and working in a Win 10 environment
- Experience of SQL databases is an advantage
- Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
- S/he is expected to be self-motivated and develop an understanding of the business.
- Self-Motivation, use initiative to identify and drive improvements
Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.