Engineer 2, Sterilization

Cook Group; Ellettsville (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Cook Group is seeking a Sterilization Engineer 2 in Ellettsville, Indiana to support daily operations and enhance equipment and processes. The role involves ensuring compliance with regulatory standards while innovating sterilization methods.

Candidates should possess a Bachelor's degree in Engineering and a minimum of 2 years of experience. Skills in AutoCAD and knowledge of FDA regulations are essential. The position entails 20% travel and offers a supportive environment for ongoing training.

Qualifications

• Minimum of 2 years of engineering experience required.
• Knowledge of sterilization and related ISO standards mandatory.

Responsibilities

• Support project planning and equipment/system qualification.
• Develop and improve sterilization processes and training.
• Adhere to QMS and regulatory standards for sterilization.

Skills

GMP knowledge

FDA regulations

AutoCAD proficiency

Microsoft Office

Education

Bachelor's degree in Engineering or related disciplines

Tools

AutoCAD

REVIT/BIM

Job description

Overview

The Sterilization Engineer 2 works cross-functionally to support daily sterilization operations, as well as local and global process and equipment improvement projects, to meet the needs of the local entity and global organization. The position will utilize multiple engineering and scientific disciplines to support complete life-cycle of projects, equipment, and systems.

Responsibilities

• Support in project planning, documentation, design, construction, start-up, commissioning, and qualification equipment, and systems.


• Read and comprehend drawings, and specifications to develop/modify CAD drawings for equipment, facility, or systems.


• Develop, maintain, improve sterilization process and equipment, and provide associated training.


• Define and create technical specifications and validation documentation for a wide variety of projects.


• Ensure new or modified asset information is properly transferred into Maintenance and Calibration systems.


• Possess the ability to support multiple complex projects with a high level of detail and accuracy.


• Understand complex systems and be able to identify potential areas of improvement.


• Ability to work hands on and support calibration requirements with critical equipment/systems.


• Adhere to the QMS and its processes to meet FDA 21 CFR 820, 210, 211, ISO 13485, ISO 11135 and other applicable regulatory requirements.


• PLC interface and configuration/troubleshooting of such equipment.


• Continuously improve existing processes, equipment, and systems using conceptualizing, rationale, reasoning, and interpretation.


• Support investigations to understand root cause of technical problems.


• Maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.


• Serve as technical subject matter expert (in training) for sterilization equiment and process.

Qualifications

• Bachelor's degree in Engineering, Engineering Technology, or related disciplines.


• Minimum of 2 years experience.


• Working knowledge of GMP, FDA 21 CFR 820, 210, 211, ISO 13485 and other ISO regulations pertaining to sterilization.


• Working knowledge of AutoCAD, REVIT/BIM, or other similar software.


• Proficient in Microsoft Office software (Word, excel, powerpoint, Outlook, etc.).

Physical Requirements

• Ability to travel approximately 20% as necessary to other facilities.


• Work under general office environment conditions.


• Utilize close visual acuity for working with computers and equipment.


• Frequently required to sit, stand, walk, and communicate.


• Occasionally lifting with maximum exertion during shift.