LIMS Validation Consultant

CSols Inc. is the leading Laboratory Informatics Solutions Provider in North America. We prioritize integrity, quality, and high value in all our relationships with employees, clients, and partners. Our commitment to social responsibility includes allocating a portion of profits to help those in need. We offer expertise and services to plan, implement, integrate, and validate industry-leading laboratory informatics solutions efficiently and effectively. Our People Our consultants possess a unique combination of technology, science, and domain experience. Culture Our company culture is built on eight core values: Team Player, Strong Work Ethic, Smart, Excellence, Accountable, Professional, Humble, and Integrity. This strong culture has contributed to our recognition as a Top Workplace in Delaware eight times since 2014. Position Overview CSols, Inc. is looking for a results-driven Informatics Validation Services Consultant. This role is ideal for a validation professional who is ready to move beyond traditional CSV “box-checking” and embrace Computer Software Assurance (CSA) and risk-based testing to deliver high-quality laboratory informatics solutions. This position may require Travel up to 25% of the year. Responsibilities Execute Modern Validation: Perform validation activities for GxP systems (LIMS, CDS, ELN, etc.) using CSA principles, focusing efforts on high-risk functional testing rather than low-value documentation. Deliverable Ownership: Independently author and execute core validation assets, including Risk Assessments, User Requirement Specifications (URS), Traceability Matrices, and Summary Reports. Agile Testing: Develop and execute streamlined test scripts (unit, integration, and user acceptance) that leverage unscripted testing where appropriate under CSA guidelines. Support Emerging Tech: Assist in the validation of systems incorporating data transformation and advanced data analytics, ensuring they meet GAMP 5 requirements for “fit for intended use.” Process Efficiency: Proactively identify opportunities to use digital tools or automated templates to speed up the validation lifecycle without sacrificing quality. Collaborative Liaison: Interface daily with client SMEs and CSols project leads to ensure timelines are met and project risks are communicated early. Requirements Qualifications Education: Bachelor’s degree in laboratory science (e.g., chemistry, biology, microbiology, pharmacology, immunology). Experience: 3-6 years of experience in a regulated laboratory environment (GxP), with a specific focus on informatics validation. Technical Knowledge: Hands-on experience with at least one major system (e.g., LabWare, LabVantage, Empower, Sapio Sciences). Modern Compliance: Familiarity with FDA’s CSA guidance and a solid understanding of 21 CFR Part 11. Critical Thinking: Ability to apply a risk-based approach to determine “how much testing is enough,” moving away from the “one-size-fits-all” CSV model. Efficient Execution: Proven ability to manage multiple deliverables across parallel projects, prioritizing tasks based on project impact and deadlines. Tech Savvy: Comfortable using Digital Validation Management systems (e.g., ValGenesis) or advanced ALM tools. Independent 1099 Contractors are welcome to apply as well. Independent contractors would not be eligible for benefits Benefits Drive meaningful change by helping our clients bring safe, effective products to market faster through modern, risk-based validation excellence. Be part of a Top Workplace in Delaware, recognized for its strong culture and values. Contribute to a company that makes a positive impact on the world. Work with a team of experienced and passionate professionals. 401(k) – company contributes a mandatory 3% annually #J-18808-Ljbffr