Histotechnologist / Validation Specialist

Viltis Consulting; Illinois; Sur place; USD 55 104 - 82 656; Plein temps

Résumé du poste

Viltis is seeking an experienced Histotechnologist / Validation Specialist to support a DHF remediation initiative for a global medical device manufacturer in Richmond, Illinois. This on-site contract role combines hands-on histology with regulatory documentation and design controls.

Responsibilities include developing validation protocols, executing studies, preparing tissue processing and embeds, and authoring validation reports and DHF documentation while collaborating with engineering and

Qualifications

• Bachelor's degree in Biology, Biomedical Science, or related life science field.
• HT(ASCP) certification or equivalent histology experience.
• Minimum 2 years in a regulated industry supporting design control/documentation.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications.

Responsabilités

• Develop validation protocols evaluating product requirements, intended use, and user needs.
• Execute simulated-use and representative-use validation studies.
• Prepare, process, embed, section, stain, coverslip, and evaluate tissue specimens.
• Document observations, deviations, and evidence; prepare validation reports.
• Author and review DHF documentation; maintain GDP and quality records.

Connaissances

Histology laboratory skills

Written and verbal communication

Attention to detail

Formation

Bachelor's degree in life sciences

Outils

Microsoft Office

Description du poste

Histotechnologist / Validation Specialist
Scientific Richmond , Illinois Contract Jul 6, 2026

Histotechnologist / Validation Specialist

Location: Richmond, Illinois (On-Site)
Job Type: Contract (6 Months)
Schedule: Full-Time | Monday–Friday | Day Shift (40 Hours/Week)
Expected Start: July 2026

About Viltis

Viltis is a life sciences consulting firm connecting exceptional scientific and engineering professionals with leading biotechnology, pharmaceutical, and medical device organizations. We are currently seeking an experienced Histotechnologist / Validation Specialist to support a critical Design History File (DHF) remediation initiative for a global medical device manufacturer.

This role is ideal for a hands-on histotechnologist who enjoys working at the intersection of laboratory science, product development, and quality systems. You'll play a key role in validating histology workflow products while contributing to regulatory documentation supporting medical device compliance.

Position Overview

The Histotechnologist / Validation Specialist will independently execute histology workflows while supporting validation activities for consumable medical device products. This position combines laboratory expertise with technical documentation and design control responsibilities, ensuring products meet user requirements, intended use, and regulatory expectations.

The ideal candidate has experience working in regulated environments and is comfortable performing laboratory work while authoring validation protocols, reports, and Design History File documentation.

Key Responsibilities

Validation & Product Testing

• Develop validation protocols that evaluate product requirements, intended use, workflow performance, and user needs.
• Execute simulated-use and representative-use validation studies.
• Prepare, process, embed, section, stain, coverslip, and evaluate tissue specimens.
• Document observations, deviations, usability findings, workflow limitations, and objective evidence.
• Prepare validation reports with conclusions traceable to acceptance criteria.

Design Controls & Documentation

• Author and review Design History File (DHF) documentation.
• Support product requirements and technical specifications.
• Contribute to risk management documentation.
• Prepare validation protocols, reports, and supporting technical documentation.
• Maintain accurate documentation in accordance with quality system requirements.

Laboratory & Quality Support

• Perform routine histology procedures with a high level of accuracy.
• Troubleshoot workflow and specimen preparation issues.
• Support product development activities through objective laboratory testing.
• Collaborate with engineering, quality, and cross-functional project teams.
• Follow Good Documentation Practices (GDP) and applicable quality procedures.

Required Qualifications

• Bachelor's degree in Biology, Biomedical Science, Medical Laboratory Science, Histotechnology, Pathology, Anatomy, Physiology, Chemistry, or another related life science discipline.
• HT(ASCP) certification or equivalent professional histology laboratory experience.
• Minimum of 2 years of experience working in a regulated industry supporting design control or product development documentation.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

Experience with:

• Paraffin embedding
• Microtomy
• Routine H&E staining
• Coverslipping
• Histology artifact troubleshooting
• Reagent preparation and management
• Controlled laboratory documentation
• Validation protocols and technical reports
• Medical device design controls and DHF documentation
• ISO 13485 and/or ISO 9001 quality systems

What We're Looking For

Successful candidates will demonstrate:

• Strong hands-on histology laboratory skills
• Excellent technical writing abilities
• Attention to detail and documentation accuracy
• Ability to work independently with minimal supervision
• Critical thinking and scientific problem-solving skills
• Experience distinguishing product-related issues from specimen, technique, reagent, or equipment variables

Why Join Viltis?

At Viltis, you'll have the opportunity to work on meaningful projects supporting innovative medical technologies that improve patient care worldwide. We partner with leading life sciences organizations to provide challenging assignments where your expertise directly contributes to product quality, regulatory compliance, and successful product development.

If you're an experienced Histotechnologist looking to apply your laboratory expertise in a product validation and medical device development environment, we'd love to hear from you.