CSV Validation Engineer

3 weeks ago

Indianapolis, United States Darwin Recruitment Full time
Senior CSV Engineer (LIMS/Instrument Validation)

Responsibilities:

  • Configure and operate laboratory systems, ensuring smooth and efficient performance.
  • Execute validation activities across various LIMS platforms, ensuring compliance and accuracy.
  • Deep understanding of the lab's sample workflow and business processes.
  • Develop LIMS-specific requirements derived from workshop discussions and client interactions.
  • Interpret and independently apply client quality standards, cGMPs, and regulatory guidelines to support validation efforts.
  • Conduct independent verification of test results against specifications.
  • Collaborate with client quality representatives to resolve issues, investigate deviations, and perform root cause analysis during project execution.
  • Work with bench-top analytical instruments, including chromatography systems, integrating them into LIMS workflows.

Requirements:

  • Must be able to work onsite in Indianapolis, IN.
  • Bachelor's degree or equivalent required.
  • Direct experience working within or on a LIMS system.
  • Knowledge of Orchard LIMS, specifically to support commercial labs.
  • Ability to create requirements documents and business process workflows.
  • Diagnostic lab expertise is highly preferred.
  • Comprehensive understanding of Master Data and other necessary records for optimal LIMS functionality.
  • Proven experience in gathering requirements for large-scale LIMS implementations.
  • Ability to analyze and refine lab business processes to leverage the benefits of electronic sample management systems.
  • Proficiency with PCs and Microsoft Office tools.
  • Excellent communication skills, able to articulate ideas clearly and concisely to peers and clients.
  • Strong problem-solving and critical thinking capabilities.
  • Strong organizational skills and effective time management.
  • High attention to detail and accuracy.
  • Familiarity with GMP and Good Documentation Practices.
  • Intermediate experience with WORD (creating/editing technical documents with styles, tables, TOCs, and track changes).
  • Basic knowledge of EXCEL and PowerPoint.
  • Strong interpersonal and communication skills.
  • Able to manage high levels of challenge and adapt to change.
  • Ability to mentor and support junior team members.
  • Experience in leading client communication and managing expectations.
  • Ability to identify new business opportunities and report these to leadership.
  • Experience conducting risk assessments and setting project goals for Verista products.
  • Flexibility to work both independently and as part of a collaborative team.

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.

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