Histology Validation Scientist – On‑Site, Day Shift

Viltis; Richmond (IL); On-site; USD 55,000 - 69,000; Full time

Job summary

Viltis is seeking an experienced Histotechnologist / Validation Specialist to support a medical device manufacturing organization in Richmond, Illinois. This on-site role will support histology product validation and Design History File remediation activities.

The ideal candidate combines hands-on histology laboratory experience with experience developing and executing validation protocols within a regulated environment.

Qualifications

• Bachelor's degree in Biology or 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.

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.

Skills

Test protocol development

Validation documentation

Quality systems

Education

Life sciences degree

Tools

MS Office

Job description

Viltis is seeking an experienced Histotechnologist / Validation Specialist to support a medical device manufacturing organization in Richmond, Illinois. This on-site role will support histology product validation and Design History File remediation activities.

The ideal candidate combines hands-on histology laboratory experience with experience developing and executing validation protocols within a regulated environment.