Experienced Validation Engineer – Medical Device Manufacturing - Quality Assurance and Regulatory Compliance in Marion, NC

Join the Team That's Saving and Sustaining Lives At Baxter, we're on a mission to make a positive impact on patients around the world. For over 85 years, we've been pioneering significant medical innovations that transform healthcare. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home. We're looking for a talented Validation Engineer to join our team in Marion, NC, and be part of a company that values quality, innovation, and teamwork. About the Role As a Validation Engineer at Baxter, you'll play a critical role in ensuring that our medical devices and systems meet the highest standards of quality and regulatory compliance. You'll be responsible for providing hands-on validation support to several facilities, utility, and equipment qualifications. Your expertise will help us maintain the integrity of our systems, from Automated Visual Inspection Systems to Water for Injection systems. Key Responsibilities: Provide hands-on validation support for facility, utility, and equipment qualifications Perform process validation, process capability, and process control studies for assigned projects Support Manufacturing, QC, Engineering, and Quality Management departments with the development and implementation of new processes and technologies Participate in medium to large-size projects, own work, and produce detailed requirements and analysis documents Partner with other support groups and manufacturing teams to complete work Ensure FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation and USP Chapter Visual Inspection of Parenterals Develop test requirements and prepare and document test data for complex system testing Provide support to resolve technical issues with systems under validation Ensure computer systems and applications follow regulatory quality standards through validation activities Requirements and Qualifications Essential Qualifications: Bachelor's degree in Engineering (ME, IE, CHE, BME, EE, CE) Minimum of 3 years of validation experience in the pharmaceutical/biotech industry Experience with quality assurance and/or validation in a regulated industry Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project Understanding of software systems and how to test them Preferred Qualifications: Experience with Wonderware, Allen-Bradley PLC Familiarity with IQ/OQ/PQ and Data Integrity (ALCOA) What We Offer At Baxter, we're committed to creating a work environment that's engaging, challenging, and rewarding. Here are just a few benefits of working with us: Compensation and Benefits: Competitive salary range of $60,000 to $132,000 per year Annual incentive bonus 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 Work Environment and Culture: Opportunity to work in a dynamic and fast-paced medical device manufacturing environment Collaborative and supportive team culture Recognition and rewards for outstanding performance Opportunities for professional growth and development Why Join Baxter? At Baxter, we're passionate about saving and sustaining lives. We're committed to creating a work environment that's engaging, challenging, and rewarding. Here are just a few reasons why you should consider joining our team: Make a Difference: Be part of a company that's making a positive impact on patients around the world Contribute to the development of life-saving medical innovations Work with a talented team of professionals who share your passion for quality and innovation Grow Your Career: Opportunities for professional growth and development Collaborative and supportive team culture Recognition and rewards for outstanding performance How to Apply If you're a motivated and talented Validation Engineer looking for a new challenge, we want to hear from you! Please submit your application, including your resume and cover letter, to [insert contact information]. We can't wait to discuss how you can join our team and make a difference in the lives of patients around the world. Equal Employment Opportunity Baxter is an equal opportunity employer. We evaluate 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 you need a reasonable accommodation for any part of the application or interview process, please let us know. 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 [insert link to recruitment fraud notice]. Apply for this job