Engineer 2, Sterilization

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.
• Able 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.
• 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.).