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Dice - Indiana
Engineer 2, Sterilization
Career Insights for Process Development Engineer
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Based on Indiana data
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What they do
A Process Development Engineer designs and implements production systems in manufacturing, engineering or mining. Develops processes that are efficient and cost effective. Plans, implements and tests production systems and processes and ensures compliance with industry and regulatory standards.
$113,802 / year median in Indiana
+6% projected growth
Job Description
Cook Group Apply Now Engineer 2, Sterilization Ellettsville, IN, US
- Posted 30+ days ago
- Updated 4 hours ago Full Time On-site Fitment Dice Job Match Score™ To see how well you match this job, please log in or create an account .
GMP ISO 13485 ISO 9000
AutoCAD Autodesk Revit Building Information Modeling Microsoft Office Microsoft Excel Microsoft PowerPoint Microsoft Outlook System Integration Testing Project Planning Specification Gathering Documentation QMS Programmable Logic Controller Reasoning ROOT Continuous Integration and Development TrainingGMP ISO 13485 ISO 9000
AutoCAD Autodesk Revit Building Information Modeling Microsoft Office Microsoft Excel Microsoft PowerPoint Microsoft Outlook System Integration Testing Show more Summary Overview The Engineer 2, Sterilization 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.
Dice Id:
80183843Position Id:
e136a7e7a7cb7f575dfe780a9f72028f Posted 30+ days ago Create job alert Never miss an opportunity! Create an alert based on the job you applied for. Create alert Similar Jobs Novo Nordisk Inc Engineer, Process- Drug Substance Bloomington, Indiana
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