Informatics Validation Consultant — CSA & Risk-Based Testing

CSols, Inc.; Delaware; Hybrid; 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

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.