Histotechnologist / Validation Specialist
viltisRichmond (IL)
About the role
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.
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