Engineer 2, Sterilization

Cook Medical; Ellettsville (IN); On-site; USD 70,000 - 85,000; Full time

Job summary

Cook Medical is seeking a Sterilization Engineer 2 located in Ellettsville, Indiana. This role involves supporting daily sterilization operations and improving local and global processes. The ideal candidate should have a Bachelor's degree in Engineering, at least 2 years of experience, and knowledge of regulatory requirements. Proficiency in AutoCAD and Microsoft Office is preferred. The position includes project planning, technical documentation, and process improvement responsibilities.

Qualifications

• Bachelor's degree in Engineering, Engineering Technology, or related disciplines.
• Minimum of 2 years experience.
• Knowledge of GMP, FDA, ISO regulations.
• Working knowledge of CAD software.

Responsibilities

• Support in project planning, documentation, design, construction, and qualification.
• Develop and maintain sterilization processes and equipment.
• Adhere to QMS processes to meet regulatory requirements.
• Identify potential areas of improvement in complex systems.

Skills

GMP knowledge

Project management

Communication skills

Problem-solving

Education

Bachelor's degree in Engineering

Tools

AutoCAD

REVIT/BIM

Microsoft Office

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 equipment 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.

We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class. Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.