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.

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