New

Manufacturing Validation Associate II

Baxter
parental leave, paid time off, paid holidays, 401(k), employee discount
United States, Illinois, Round Lake
25212 Illinois 120 (Show on map)
Apr 21, 2026
This is whereyour work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your role at Baxter Must not be allergic to Cephalosporins or Penicillin. This role is primarily focused on handson validation activities for manufacturing equipment, processes, utilities, and facilities within an onsite GMP manufacturing environment. The position supports the development and execution of validation deliverables related to equipment qualification, process validation, cleaning validation, and utilities/facility validation for commercial manufacturing operations. The ideal candidate will have direct experience executing validation activities on the manufacturing floor r Validation activities include research, IQ/OQ/PQ and PPQ protocol writing and execution, analysis of results, and final report generation. The role also supports investigation of manufacturing challenges, equipment and process improvements, and implementation of validated solutions. Final documents are archived and may be included in or support A/NDA submissions and made available during FDA and customer compliance audits. What you'll be doing Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment. Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment. Lead and support cleaning validation activities, including protocol execution and sampling activities. Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies. Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to crossfunctional teams. Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas. Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation. Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities. Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations. Provide limited support for validation of manufacturingassociated computerized or equipmentintegrated systems, as applicable to overall equipment or process validation. Review and generate quality documents including validation protocols, SOPs, change controls, and nonconformance investigations. Serve as a project lead for validation projects of intermediate scope, coordinating with Manufacturing, Engineering, Maintenance, Quality, and MSAT. Support regulatory inspections and responses related to manufacturing validation activities. Effectively prioritize workload and manage multiple validation activities while maintaining compliance with procedures and schedules. What you'll bring BS Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience. 2 years of direct, handson experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment. Ability to work at least 5 days onsite in the plant Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred. Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges. Good interpersonal/communication/influencing/negotiation skills. Strong project management skills Ability to communicate effectively at all levels in verbal and written form, including technical/business writing. Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful. Direct or indirect industry knowledge. Ability to work independently or in teams. Physical demands of the position may require the ability to lift materials up to 20 lbs, dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces. 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 $88,000 - $121,000 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.This position may also be eligible for discretionary bonuses. 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. 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. #LI-RS1 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. Know Your Rights: Workplace Discrimination is Illegal 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.