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Senior Manager, Sterilization Engineering

Company: Baxter
Location: Round Lake
Posted on: June 6, 2021

Job Description:

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Summary:

For this role, you will consult and collaborate with site leadership, sterility assurance and sterilization engineering to support development, validation and maintenance of all sterilization equipment and processes across Baxter sites. This role will focus initially on ethylene oxide sterilization and will be located preferably in Illinois, and open to other locations near Baxter's larger manufacturing sites.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):

  • Provide global manufacturing support to audit and assess processes for operational performance, safety, and regulatory compliance

  • Develop scope, cost(capital and operational), and timelines in support of capital projects and execution

  • Complete understanding of equipment, operational mechanics, ancillary facilities equipment, as well as new/alternate technology trends on the market. Additionally, an understanding of abatement technologies commercially available for emission control for regulatory compliance.

  • Thorough understanding of all instrumentation technologies and calibration requirements to maintain, monitor, and control a safe operation within regulatory permit requirements.

  • Support the development of validating sterilization processes for new and existing products

  • Reviewing and evaluating non-conformances, performing root cause analysis, and proposing corrective/preventive actions

  • Generating and updating engineering documents such as drawings, manufacturing/quality instructions, test methods, and test protocols/reports

Job Requirements (Education, Experience and Qualifications):

  • Bachelor of Science in Engineering discipline, preferably Mechanical or Chemical Engineering

  • Minimum 10 years engineering experience with at least 3 years in medical device sterility assurance, sterilization operations, or related processes

  • Demonstrated knowledge EO sterilization equipment and systems

  • Demonstrated knowledge of packaging and product design issues as related to sterilization processes

  • Ability to develop innovative solutions to complex problems

  • Preferred: Knowledge regarding the development, implementation, and maintenance of OSHA 29 CFR 1910.119 "process safety management of highly hazardous chemicals" regulatory requirements as it relates specifically to ethylene oxide

  • Preferred: knowledge regarding the development, implementation, and maintenance of Environmental Protection Agency (EPA) 40 CFR Part 68 "risk management program" regulatory requirements as it relates specifically to ethylene oxide.

  • Preferred: knowledge of emergency action and responses plans as it relates specifically to ethylene oxide

  • Preferred: knowledge of conducting, leading and/or participation in Process Hazard Analysis Studies

  • Preferred: knowledge of Occupational Safety & Health Administration (OSHA) 29 CFR 1910.1047 "ethylene oxide" regulatory requirements to assist in ensuring the safety and health of our employees at the facility.

Physical / Safety Requirements

  • Travel required based on business needs (US and Abroad). Up to 50% based on business need. Initially will spend 18-24 months onsite in Mountain Home, Arkansas

  • Duties may require overtime work, including nights and weekends

  • Position requires standing and walking for extended periods of time in a operations environment

#LI-LH1

#IND-USOPS

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

041520

Keywords: Baxter, Arlington Heights , Senior Manager, Sterilization Engineering, Other , Round Lake, Illinois

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