Engineer 2, Sterilization

Based onsite in Ellettsville, Indiana, this role supports daily sterilization operations and drives cross-functional process and equipment improvements at both local and global levels.

Responsibilities

• Assist with project lifecycle activities for sterilization equipment and systems, including planning, documentation, design, construction, start-up, commissioning, and qualification.
• Review drawings and specifications to create or revise CAD models for equipment, facilities, or systems.
• Develop and sustain sterilization processes and equipment; provide related training to staff.
• Prepare technical specifications and validation documentation across a broad range of projects.
• Ensure asset information is accurately transferred into maintenance and calibration systems for traceability.
• Coordinate multiple complex projects with high attention to detail and accuracy.
• Analyze complex sterilization systems to identify improvement opportunities.
• Provide hands-on support for calibration requirements on critical equipment and systems.
• Adhere to the quality management system and regulatory requirements including FDA 21 CFR 820, 210, 211; ISO 13485 and ISO 11135.
• Interface with PLCs, configure and troubleshoot related equipment.
• Continuously improve processes, equipment, and systems through analysis, rationale, and interpretation.
• Support investigations to determine root causes of technical problems.
• Maintain required role training and pursue ongoing development opportunities.
• Serve as a technical subject matter expert in sterilization equipment and processes, including training others.

Requirements

• Bachelor's degree in Engineering, Engineering Technology, or a related discipline.
• Minimum of 2 years of relevant experience.
• Working knowledge of GMP, FDA 21 CFR 820, 210, 211, ISO 13485 and related ISO sterilization regulations.
• Working knowledge of AutoCAD, REVIT/BIM, or equivalent CAD software.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Technologies

• AutoCAD
• REVIT/BIM
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Outlook

Overview

The Engineer 2, Sterilization role collaborates across functions to support daily sterilization operations as well as local and global process and equipment improvement initiatives. Located onsite in Ellettsville, IN, the position utilizes multiple engineering and scientific disciplines to support the complete lifecycle of projects, equipment, and systems.

Physical Requirements

• Travel approximately 20 percent to other facilities as needed.
• Work in a general office environment with standard conditions.
• Close visual acuity for performing computer and equipment tasks.
• Frequent sitting, standing, walking, and communication.
• Occasional lifting with maximum exertion during shift requirements.