LIMS Validation Consultant

CSols, Inc.; Delaware; On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) – company contributes a mandatory 3% annually

Recognition as a Top Workplace in Delaware

Opportunities to make a positive impact

Job summary

A leading laboratory informatics solutions provider in Delaware is seeking an Informatics Validation Services Consultant to embrace modern validation principles and deliver high-quality solutions. The role requires 3-6 years of GxP experience and involves performing validation activities and developing test scripts. Ideal candidates should have a bachelor's degree in laboratory science and familiarity with digital validation tools. This position may also be open to independent contractors interested in contributing to meaningful work.

Qualifications

• 3-6 years of experience in a regulated laboratory environment (GxP).
• Familiarity with FDA’s CSA guidance and 21 CFR Part 11.
• Ability to manage multiple deliverables across parallel projects.

Responsibilities

• Perform validation activities for GxP systems using CSA principles.
• Independently author and execute core validation assets.
• Develop and execute streamlined test scripts under CSA guidelines.
• Assist in the validation of systems with data transformation.

Skills

Validation activities for GxP systems

Technical knowledge of LabWare, LabVantage, Empower

Risk-based testing

Digital Validation Management systems

Education

Bachelor’s degree in laboratory science

Tools

ValGenesis

ALM tools

Job description

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