Job Description

Responsible for assisting in Quality Critical System and Facility Design and Maintenance, in addition to providing technical support and service to these areas, the incumbent may also perform the following functions: supervising, requisitioning, defining, initiating, specifying, documenting, and training. Works independently performing standard commissioning and qualification work requiring application of cGMP practices, procedures, and criteria. Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. Act independently with minimal direction to conduct approved projects. Possess the technical knowledge required to complete assigned responsibilities. Able to complete work you're doing in a variety of subject areas, including change control, protocols, analytical equipment qualification, method validation, cleaning validation, and process validation. Ability to work multi-functionally to establish working unions with other department representatives. Responsible for scheduling tasks and meeting plant requirements for area in which you are assigned. Investigate and analyze customer service problems and process improvement suggestions. Recommend process improvements. Be able to defend and connect with external auditors. Develops and or lead in the development of solutions to problems specific to assigned projects. Able to lead or assist continuous improvement projects. Works with manufacturing and other functional groups on manufacturing regulatory compliance issues. Writes, implements, and reports on validation activities. Coordinates validation issues specific to the product/process design, validation, and ongoing monitoring. Writes and/or implements qualification protocols for various analytical equipment, methods, cleaning, and manufacturing processes. Designs and performs routine testing, project experiments, analysis of data and reports results. Performs studies on new processes to optimize critical process parameters, etc. including data gathering during test batches. Initiates new or revisions of protocols/operating instructions specific to the project. Performs work assignments within production department that include training, technical support and/or process trouble shooting support. Interprets, implements, and recommends modifications to operating policies where appropriate. Bachelor’s Degree in science, engineering, or related field and 3 – 6 years proven experience in commissioning, qualification, and validation from a cGMP environment (in-house, co-op or acquired outside). Ability to discuss normally encountered technical or project management issues, both verbally and in written form. Ability to tackle routine analytical or process related problems. Ability to perform statistical analysis of data collected throughout various projects. Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words, process flow diagrams, and related drawings. Must have good English written and oral communication skills. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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