Marion, North Carolina
1 day ago
Validation Technician (7:00am-7:00pm)

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

Assure that equipment validation and manufacturing processes align with Corporate and Plant requirements. Work with engineering, manufacturing, maintenance and quality to assure equipment availability/ acceptance and production throughput. Provide data for inclusion in reports to regulatory agencies.

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 OneShift flexibility to trade shifts and leverage overtime opportunitiesMedical, Dental and Vision coverage160 hours of Paid Time Off and Paid Holidays401K matchEmployee Stock Purchase ProgramPaid Parental LeaveTuition ReimbursementWhat you'll be doing1. ValidationConduct qualification, requalification and evaluation studiesDetermine test requirements based on specification or protocol instructionsPrepare and perform software testingPrepare and perform testing to high confidence levelsPerform statistical studies/ data entry for Mini-tab and other statistical packagePrepare report using Excel, Word and PowerPointPerform studies per specification or protocolEvaluate results against specification, SOP or protocol requirementsIdentify out of specification/protocol conditions and issue exception reports.Analyze data, materials and/or equipment to determine the cause of out of limits or exception conditionsPrepare study package for management review and approvalReview/approve change maintenance requestsPerform protocol closure duties including labeling, assembling packages and routingPerform protocol retrieval, storage and audit functions to assure proper filing and documentation.Lead and/or direct protocol efforts and project validations including external protocols2. Process ImprovementPrepare monthly and quarterly trend reportsPerform statistical studies/ data entry for Mini-tab and other statistical packagePrepare and perform gauge repeatability and test method studiesPerform capability and other acceptance functional testingDevelop and apply physical testing on product as neededReview other certifications per applicable specifications3. Cross Functional Duties:Perform audits and assessments to assure compliance with regulatory requirementsServe as SMEHost internal and external meetings as requiredPerform training as neededWork with scheduling, production, quality and sterilization departments to schedule activitiesTalk to Corporate as neededAssist with risk based analysis and approve changesServe as project lead when needed.Notify the supervisor and take appropriate action if any safety, quality or discrepancy issues occurLearn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)Sustain a clean and safe work area using 6S principles including maintaining and securing provided toolsWork EnvironmentCan include working in a Class I, Class II, Class III or Class IV Controlled Environment which may include the following dress/gowning requirements: safety glasses, ear plugs, hairnet, beard cover, isolation mask, gown, hood, boots or shoe covers and gloves. Additional PPE is required when cleaningThere is constant or intermittent noise and vibrationThis position involves working around moving equipment, machinery and conveyorsWhat you'll bringAssociate Degree with specialization in technical area, such as, metrology, instrumentation, electronics, mathematics, science or statistics OR 2 years of relevant experience.Basic Skills Training with demonstrated experience in the areas of project management, validation and testing.Experience in statistical and data analysis techniques.Must have basic English written and oral communication skills adequate to communicate with other team membersUnderstand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawingsMust be able to perform advanced level mathematicsProven problem solving and analysis in the evaluation of test data and determination of data acceptability or validation of critical systems or equipment with responsibility for preparing test equipment and documentation, and identifying potential problems during validation studies.Process improvement experience in developing test plans, testing and completing technical reports. (preferred)Other Training /Experience (preferred)Proficient in: AS400, Trackwise, Maximo, Excel, word and Power PointPhysical RequirementsRequires the ability stand/walk frequently throughout the shift.Ability to lift and carry up to 34 poundsMust be able to squat, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance

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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $40,000 - $55,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Other Duties as Assigned

Please note this job description is not designed 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

Must be willing to work during plant downtime periods, including weekends and other shutdown periods.

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

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

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 Recruitment Fraud Notice.

Confirm your E-mail: Send Email