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CSV Engineer

3 months ago

Delhi, India Pharmatek Consulting Inc Full time
Job DescriptionCSV EngineerLocation: Elkton,VA, Durham, NCDuration: 9 month project - Start date is as early as August;The resource will not need to travel between sites, but will need to be local and able to go on-site everyday to either location (Durham or Elkton VA).

Requirements:

Must have CSV QA/quality experience; the ideal candidate will have performed the final QA signature on the entire SDLC documentation suite.- Delta V experience.- Strong Data Integrity knowledge; knowledge of principles, how to apply them, and how to improve and implement data integrity.

Requirements

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 incidentreports, etc.)o 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 activitiesRequirementsAt least 3 years’ experience/ knowledge with automated systems, including programming and improving complex systems Familiarity with at least one computer coding language (such as Python, Java, C#, HTML), understanding in version control systems (like GitHub or GitLab) is a plus Able to independently contribute through development and optimization of automation technologies preferred. Able to oversee implementation of automation technologies with third parties through technical skills and project management principles Must be able to work productively in an interdisciplinary team environment Experience with Hamilton, Scinomix, Tecan or similar automated laboratory platforms preferred Good oral and written communication, problem-solving, and analytical skills Ability to influence and educate other scientists and engineers to use automation technologies as part of implementation Proficiency using PC and Microsoft Office tools Excellent organizational and time management skills Strong attention to detail GMP and Good Documentation Practice Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes) Basic skills with EXCEL and PowerPoint Experience with and tolerance for high levels of challenge and change Experience with project management including capturing project requirements and deliverables, timeline development, stakeholder management and communications