Histotechnologist / Validation Specialist
Location: Richmond, IL Schedule: Monday–Friday, 40 hours/week | Day Shift Duration: 14-month contract, through the end of 2027 Start Date: October 2026 Pay Rate: $40–$50/hour Work Arrangement: On-site only; relocation assistance is not available
Position Overview
Viltis is seeking an experienced Histotechnologist / Validation Specialist to support a medical device manufacturing organization in Richmond, Illinois. This role will support histology product validation and Design History File (DHF) remediation activities.
The ideal candidate combines hands-on histology laboratory experience with experience developing and executing validation protocols within a regulated environment. This individual will perform representative histology workflows, evaluate product performance, document findings, and develop controlled validation documentation supporting design-control requirements.
Responsibilities
- Develop user-validation and applications-testing protocols addressing product requirements, intended use, user needs, and workflow performance.
- Define test conditions, representative workflows, acceptance criteria, observations, and required objective evidence.
- Execute simulated-use and representative-use testing using standard histology workflows.
- Prepare, process, embed, section, stain, coverslip, and evaluate tissue specimens.
- Perform tissue processing, paraffin embedding, microtomy, H&E staining, reagent handling, and slide quality assessment.
- Identify and document deviations, usability issues, workflow limitations, and other findings.
- Differentiate product-related findings from variations associated with technique, specimens, reagents, or equipment.
- Prepare validation reports with conclusions traceable to established acceptance criteria.
- Author and review DHF documentation, including product requirements/specifications, risk-management documentation, validation protocols, and validation reports.
- Maintain accurate documentation in accordance with applicable quality-system requirements.
Qualifications
Required:
- Bachelor's degree in Biology, Biomedical Science, Medical Laboratory Science, Histotechnology, Pathology, Anatomy, Physiology, Chemistry, or a related life-science discipline.
- HT(ASCP) certification or equivalent hands-on histology laboratory experience.
- 2+ years of experience in a regulated industry working with design-control documentation.
- Experience developing and/or executing test protocols.
- Proficiency with Microsoft Office.
- Basic understanding of quality systems such as ISO 9001 and ISO 13485.
Preferred:
- Independent competency in embedding, microtomy, tissue processing, routine staining, coverslipping, slide-quality review, and troubleshooting histology artifacts.
- Experience with automated or manual tissue processors, microtomes, embedding centers, autostainers, and coverslipping equipment.
- Experience documenting laboratory activities through controlled records, protocols, validation reports, or quality-system documentation.
- Strong ability to troubleshoot histology workflows and distinguish product performance issues from laboratory-process variables.
About Viltis
Viltis provides specialized consulting and workforce solutions to organizations across the life sciences industry, supporting Quality, Regulatory, Clinical, Engineering, and Scientific functions.