What are the responsibilities and job description for the CSV with Equipment Validation Engineer position at LinxAI?
Job Title
CSV or Equipment Validation Engineer
Visa : Any but need on our W2
Rate
Open based on Experience
Location
Baltimore, Maryland
Principle Duties and Responsibilities :
- Author Qualification (IQ / OQ) Final Reports for Application upgrade projects.
- Author and review validation protocols including IQ, OQ, and PQ protocols related to Computer Systems for Manufacturing equipment such as bioreactors, TFFs, tube welders, AKTAs, glove integrity testers, filter integrity testers, controlled temperature units etc.
- Author and Review of Validation Deliverables - Validation Master Plan (VMP), System Impact Assessment, Risk Assessment, User Requirement Specification Document, Design Specification Document, Configuration Specification document, Data Integrity Assessment, Application Qualification Protocol (IQ / OQ / PQ), Validation Summary Reports.
- Ensure site systems are compliant with the corporate Data Integrity program.