Process Engineer

Position Overview

Viltis is seeking a Process Engineer to support a critical Design History File (DHF) remediation initiative within a regulated medical device manufacturing environment. This role will lead cross-functional project activities focused on design controls, process validation, risk management, and technical documentation.

Key Responsibilities

• Lead and coordinate weekly project activities, deliverables, and status updates.

• Collaborate with cross-functional teams to ensure project milestones are achieved.

• Support on-site process validation efforts and equipment installation activities.

• Drive execution of remediation activities while maintaining alignment with program timelines.

• Author, review, and maintain Design History File (DHF) documentation.

• Serve as Process Validation Owner for: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).

• Develop and maintain risk management documentation, including Process Failure Mode and Effects Analysis (pFMEA).

• Support design transfer activities and documentation.

• Apply statistical analysis methods to support engineering decisions.

• Design and execute Design of Experiments (DOE).

• Support Test Method Validation (TMV) activities.

• Ensure documentation complies with applicable quality and regulatory requirements.

Preferred Technical Experience

• Experience in one or more of the following areas is beneficial but not required:

  • Blending & Formulation Processes
  • Formulations and mixing dynamics
  • Tank and vessel design
  • Process scale-up activities
  • Filling & Packaging Operations
  • Liquid dispensing systems
  • Capping and labeling equipment
  • Packaging assembly processes
  • Measurement & Analytical Systems
  • UV Spectroscopy
  • pH measurement systems
  • Viscometers
  • Moisture analyzers

Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.

• Minimum of 2 years of experience in a regulated industry utilizing design controls.

• Experience with technical documentation and validation activities.

• Strong written and verbal communication skills.

• Proficiency with Microsoft Office applications.

Success Criteria

• Performance in this role will be measured by completion of accurate, compliant, and thorough technical documentation.

• Successful execution of assigned validation and engineering activities.

• Consistent reliability, attendance, and adherence to safety requirements.

• Able to support project timelines without unnecessary rework or delays.

What Viltis Provides

• A safe and compliant working environment.

• Required equipment, tools, and PPE.

• Access to applicable procedures, systems, and training.

• Collaboration with experienced engineering, quality, and manufacturing professionals.

• Opportunity to contribute to impactful medical device development and remediation initiatives.