Description
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.