Urgently Need Validation Specialist II in Asheville, NC

Job title: Validation Specialist II

Company: Baxter

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.



Your Role at Baxter



This is where your creativity addresses challenges



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.



Your Team at Baxter



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.



What we offer from Day One



Medical, Dental and Vision coverage



160 hours of Paid Time Off and Paid Holidays



401K match



Employee Stock Purchase Program



Paid Parental Leave



Tuition Reimbursement



What you'll be doing



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.



What you'll bring



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.



We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $60,000 to $132,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.



Other Duties as Assigned



Please note this job description is not crafted to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.



The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.



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.



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 here and let us know the nature of your request along with your contact information.



Recruitment Fraud Notice



Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our . 105722

Expected salary: $60000 - 132000 per year

Location: Asheville, NC

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