Full Job Description
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Serves as the principal technical resource for the site to support development, validation and maintenance of sterilization equipment and processes. Initial primary focus to be ethylene oxide.
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.
Supports 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
Works closely with production staff and other cross-functional teams
Performs process reviews and prepares technical reports detailing equipment operation, best practices and recommended changes.
Prepares documentation in support of capital projects and ability to manage capital projects. Monitors and reports project costs including capital and cross-functional expenses. Leads project teams as needed to accomplish project objectives.
Provides on-going support of continuous improvement efforts to support yearly value improvement opportunities.
Interfaces with different functional groups and producing appropriate documentation in support of projects
Job Requirements (Education, Experience and Qualifications):
Bachelor of Science in relevant Engineering discipline
Minimum 10 years engineering experience with at least 3 years in medical device sterility assurance, sterilization operations, or related processes
Demonstrated knowledge sterilization systems
Demonstrated knowledge of packaging and product design issues as related to sterilization processes
Ability to develop innovative solutions to complex problems
Ability to work effectively in cross-functional teams
Ability to work independently and manage multiple tasks and priorities
Proficient written and verbal communication skills including Microsoft Office
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.
Duties may require overtime work, including nights and weekends
Position requires standing and walking for extended periods of time in a operations environment
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
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.