Description
Validation Engineer
Location: Westport, Ireland
My Client is looking for a Validation Engineer. The position objective is to assist with the definition and implementation of operation validation activities that ensure effective oversight of the verification and validation activities.
Validation support for the lab & manufacturing system upgrade.
Serve one of our leading pharma clients in support upgrade SCADA, Historian, Lab and other manufacturing systems in a validated environment Have to plan and execute validation activities independently, drive the team to perform test management activities in an automated environment, conduct risk assessment. To provide guidance in configuring Manufacturing software, Backup/recovery/archives. Creating compliance documents across SDLC CSV validation for different industrial automation systems, lab & manufacturing Writing SOP's, testing, validation procedure documents Defining workflows and user roles and responsibilities for various automation & manufacturing the procedures for Pharma compliant process for validating different equipment's Conducting and driving Regulatory Risk Analysis with business users and IT stakeholders.
* Minimum 9-10 years' 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
* Sound understanding of 21CFR part 11 guidelines and GMP processes
* Hands on experience in creating/reviewing compliance life cycle deliverable
* Hands on experience in IT processes in manufacturing in validating Manufacturing system including MES, PLC systems
* Good understanding of compliance documents across SDLC