Process Engineer

Role Overview

Viltis is hiring a Process Engineer for a medical device manufacturing assignment in Richmond, Illinois. This is an on-site contract role focused on supporting a Design History File (DHF) remediation effort within a regulated environment. The position belongs to the Manufacturing Science & Engineering department and is planned for a 6-month engagement, with an expected start in July or August 2026.

The schedule is full time, 40 hours per week, Monday through Friday, on an 8-hour day shift.

What You’ll Work On

• Coordinate weekly project activities, deliverables, and progress updates.
• Partner with engineering, quality, manufacturing, and operations teams to keep milestones on track.
• Assist with on-site process validation work and equipment installation tasks.
• Support remediation efforts while staying aligned with the project timeline.
• Prepare, review, and update DHF records and related technical documents.
• Act as the process validation lead for IQ, OQ, and PQ activities.
• Develop and maintain risk documentation, including pFMEA.
• Contribute to design transfer documentation and related activities.
• Use statistical tools to inform engineering decisions.
• Plan and run Design of Experiments (DOE).
• Support Test Method Validation (TMV) work.
• Ensure all documentation meets quality and regulatory expectations.

Useful Background for This Role

Experience in the following areas is helpful, though not mandatory:

• Blending and formulation work, including mixing behavior, tank/vessel design, and process scale-up.
• Filling and packaging operations, such as liquid dispensing, capping, labeling, and packaging assembly.
• Measurement and analytical systems, including UV spectroscopy, pH systems, viscometers, and moisture analysis equipment.

Required Qualifications

• A bachelor’s degree in engineering or another relevant technical field.
• At least 2 years of experience in a regulated industry where design controls are used.
• Hands-on exposure to technical documentation and validation work.
• Clear written and spoken communication skills.
• Working knowledge of Microsoft Office tools.

Preferred Experience

• Prior exposure to medical device manufacturing.
• Familiarity with quality systems such as ISO 9001 and ISO 13485.
• Background supporting DHF remediation, process validation, or product development programs.

Success Measures

• Producing complete, accurate, and compliant technical documentation.
• Delivering assigned validation and engineering tasks successfully.
• Maintaining reliability, attendance, and safety compliance.
• Supporting timelines without unnecessary rework or schedule slippage.

What the Company Provides

• A safe and compliant workplace.
• Required equipment, tools, and personal protective equipment.
• Access to procedures, systems, and relevant training.
• Collaboration with experienced engineering, quality, and manufacturing teams.
• The chance to contribute to meaningful medical device development and remediation work.

Additional Details

This contract role is based in Richmond, Illinois and requires on-site work. The assignment is expected to run for 6 months, with a start window in July or August 2026.