Quanta are currently supporting a biopharma client based in Dublin with a facility expansion project.
The client is looking for a strong CSV Engineer to support them in Computer System Validation of IT solutions being implemented to the new facility.
The enthusiastic and experienced engineer should have experience supporting a new facility / facility expansion project, looking to join the team on a long-term contract basis.
- The Engineer will provide IT systems validation and compliance expertise for newly introduced IT and digital solutions.
- The Engineer is required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
- Minimum 5 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
- Capable of relating well to other people with whom s/he comes in contact
- Manage the Computer System Validation aspect of IT projects from software install to business release
- Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Execute test scripts, analyse test results and determine the acceptability of results against pre-determined criteria
- Work with the business to identify and implement procedural controls to mitigate issues found during testing
- Initiate and implement Change Control activities in accordance with Quality Standards and Practices
- Determine solutions or recommendations for changes and/or improvements
This client will only consider candidates currently located in Ireland.
IF this role interests you, apply today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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