Job Description - CSV Engineer Durham, NC Relocation ok but local preferred Typical Responsibilities Include: CSV QA support in Durham, NC on site (link removed) Strong knowledge of Data Integrity/ALCOA, QA review and approval of SDLC documents - RS, trace matrices, protocols, change controls. Required experience:- Quality experience needed. Nice to have:- Lab experience a plus Responsibilities Review all IT CSV project and system deliverables including but not limited to:o Planso Requirementso Specificationso Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etco Summary Reportso Change Controls Review system operational and administration procedures to ensure they are adequate Document any findings of non-compliance Assist with strategy regarding remediation activities Assist with review of remediation activities Developing technical documents utilizing a simple non-technical general description. This requires understanding of highly technical automated equipment. Running test scripts and making recommendations for design or process modification based on test results. Owning validation process (or portion thereof) not only from an engineering standpoint but also from a client and team relationship standpoint. Developing and writing technical change controls from a general non-technical description of the change to a product, process, equipment, protocol, packaging, outcome, or location of equipment. Documenting the planning and design required to support the changes, approvals, and testing. Managing the overall documentation development and approval process including explanation and justification of document testing, content, and strategy from a quality and regulatory standpoint to facilitate acceptance and approval of the document by required signatories.QA