CSV EngineerAnalyst

Senior CSV Engineer/Analyst

General lab instrument validation requirements. worked in a lab or have done lab validation before for at least a year or 2

CSV expert for that one.

Needs to be a strong personality.

Needs to be onsite 4 days a week.

Needs to be able to create all different validation documents as well as know data integrity

10 plus years experience

Requirements

Responsible for supporting the validation activities for local and global systems.

• Experience in developing and maintaining validation documentation including validation plans test protocols test scripts and summary reports to align with company SOP and regulatory standards.
  
• Coordinate with technical evaluation with site subject matter experts (SMEs) of new and existing systems from a DI and CSV perspective.
  
• Responsible for coordinating with crossfunctional teams to ensure the alignment of the validation activities.
  
• Perform data integrity gap assessment and develop remediation plan for computerized systems.
  
• Responsible for creating CAPA s/Deviations and Change Requests in ServiceNow and Trackwise
  
• Experience using HPALM for authoring and executing the Test scripts.
  
• Experience in performing/supporting computer validations associated with SDLC deliverables
  

At 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