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Automation Engineer Support
PR/ US All
 

General Description • Support the Serialization team responsible for the implementation of Serialization capability. • Work closely with the Serialization resources to ensure solutions meets regulatory timelines and deliverable. • System configuration support. • Support the Operational Qualification (OQ) and developed associated documentation. • Data and test scripts in support of IQ, OQ, & PQ validation milestones. • Develop test scripts, OQ and capturing and preparing documents for review. • Support and assist in the execution of validation strategy and validation master plans. • Contribute to project URS, FS, DS and validation documents. • Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc. Minimum Requirements • Bachelor's in Engineering with 10 years of professional experience. • Knowledge and experience system configuration support. • Knowledge and experiences with Optel and SAP. • Knowledge and experience of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.

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