Description
Validation Engineer | Experience of ISA 95 | Ireland | 12 Months | Immediate
Square One require a Validation Engineer to provide validation support for lab and manufacturing system upgrade for a prestigious client in Ireland. This is an exciting opportunity for a long term contract to work on a project that will be uipgrading manufacturing systems.
Key Resobilities:
* Upgrade SCADA, Historian, Lab and other manufacturing systems in a validated environment
* Plan and execute validation actitivties independently, drive the team to perform test management activities in an automated environment
* Provide guidance in configuring Manufacturing software, Backup/recovery/archives.
* CSV validation for different industrial automation systems, lab & manufacturing
* Writing SOP's, testing, validation procedure document
* Defining workflows and user roles and responsibilities for various automation & manufacturing the procedures for Pharma compliant process for validatiing different equipments
* Conducting and driving Regulatory Risk Analysis with business users and IT stakeholders
Required skills:
* Extensive experience in validation of automation & manufacturing systems
* Techno Functional knowledge & experience of ISA 95 stack & various industrial automation and manufacturing application preferably with in Pharma industry
Desireabke skills:
* Sound understanding of 21CFR part 11 guidelines and GMP processes
* Hands on experience in IT processes in manufacturing in validating Manufacturing system including MES, PLC systems
* Good understanding of compliance documents across SDL
If you are interested in this opportunity, please apply now with your updated CV in word/PDF format.
Notwithstanding any guidelines given to level of experience sought, we will consider candidates from outside this range if they can demonstrate the necessary competencies.
Square One is acting as both an employment agency and an employment business, and is an equal opportunities recruitment business. Square One embraces diversity and will treat everyone equally: Please see our website for our full diversity statement.