Lubrizol Sterilization Engineer in Franklin, Wisconsin
Req ID: 44566
Vesta, part of Lubrizol LifeSciences, offers custom medical manufacturing services, including precision thermoplastic and silicone extrusion as well as comprehensive silicone fabrication from its ISO 13485 certified facilities. Vesta capitalizes on more than 40 years’ experience, leveraging expertise in design assistance, material selection and quality compliance to enable our customer’s success.
Vesta has served as a trusted medical device outsourcing partner for four decades, delivering innovative solutions in molding, extrusion and assembly. Our Franklin, Wisconsin location includes ISO 7 certified clean room, ISO 8 controlled environment, 116,000 ft2 (10,700 m2), 17 extruders with 12 lines, 75 molding presses and a dedicated R&D laboratory. Every one of our medical device manufacturing, assembly and support services has quality at its core. Our highly collaborative, end-to-end, medical device process validation ensures quality without sacrificing product performance.
The Sterilization Engineer is primarily responsible for assuring product and Quality Systems quality and compliance through the development, implementation and monitoring of appropriate processes, tools, metrics and goals. Specifically, the Quality Engineer position is the process owner for Clean room Qualifications, Environmental Monitoring program for clean rooms, Cleaning process, Sterilization process, Internal Audits, d New Product Development programs and Quality System related projects as assigned...
What you will do:
Develops, implements, manages and improves the Environmental monitoring process to include data trending, excursion investigations, product impact and documentation.
Role is the subject matter expert and technical advisor on Clean room environment, contamination controls, and sterilization process ( heat preferable, gamma, Ethylene Oxide concepts)
Management of outsourced laboratory services ( micro, biological indicators, bioburden, pyrogen) and sterilization services ( gamma)
Manages FDA inspection topics related to environmental controls, cleaning, sterilization process and sterilization validation and microbiological testing.
Supports new product development activities as directed through core team participation in the development of Master Validation Plans, PFMEA’s, Control Plans, Procedure and Process development
Supports investigation and resolution of NCRs and CAPAs.
Assist in other CAPA activities as directed, including complaint failure investigations and customer communications.
Role is subject matter expert on Sterilization Process ( sterilizer IQ, OQ and PQ validation ) and ongoing routine re-qualifications as required per industry sterilization standards and guidelines
Responsible for review of sterilization cycle data and product release
Maintains current knowledge of ISO 13485 and FDA QSR , Sterilization principles, ISO 14644 requirements
Analyzes inspection and testing processes, mechanisms and equipment.
Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
What you need:
Bachelor’s degree, preferably in Biology or science arena.
Minimum 10 years of experience in manufacturing related to Medical Device Industry
Mastery knowledge of ISO 13485:2003, ISO 14644, FDA 21 CFR Part 820 and Sterilization Principles
Experience with Statistical Process Control and Process Validation.
Certified Quality Engineer (ASQ) (preferred)
Experience with Process, Product and/or Software Validation
Knowledge of advanced statistical concepts
Excellent (written and verbal) communication and effective human interaction skills.
Flexible to change, and possess a high degree level of integrity and “can do attitude”.
Willing to work in a team environment and contribute to group goals
Ability to receive and provide instructions in a positive manner.
Vesta is located in Franklin WI, a growing community of 35,000 people that is located in the Southeastern portion of Wisconsin, approximately 15 miles south of Milwaukee, WI and about 60 miles north of Chicago, Il. The Southeastern portion of Wisconsin is bordered on the east by Lake Michigan, a Great Lake that has fantastic fishing and boating opportunities. The City of Milwaukee is a diverse community with many ethnic festivals that occur almost every weekend from June until September. Starting with the last week in June until the second weekend in July, the Henry Maier Festival Park, hosts Summerfest, one of the largest outdoor music festivals, highlighted by the Marcus Amphitheater, which hosts Main Stage concerts every evening. Milwaukee is also the home to Harley Davidson, the Harley Museum and Harley Davidson Bike fest every 5 years. If you are into professional sports, Milwaukee is home to the Milwaukee Brewers, who play at Miller Park, the Milwaukee Bucks who are building a new area and the Green Bay Packers are within 2 hours driving distance from Milwaukee.
Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.
Nearest Major Market: Milwaukee
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