**By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.** Pay Range: $69,800.00 - $114,800.00 Are you seeking to use your passion, vision, and creativity to make a difference in people’s lives? Do you view an innovation-driven opportunity as an investment in your future? Bring your talent to our Bio-Techne! We are seeking a Quality Validation Engineer with experience in GMP qualification and validation. This position provides you an opportunity to work with a dynamic team with diverse experiences/backgrounds. You will support with qualification /validation activities leading to new product launches. Quality is one thing Bio-Techne never compromises, and continuous improvements are key to our business. You have the opportunity to be part of this system. **Key Responsibilities:** + Draft and review qualification/validation protocols (IQ/OQ/PQ/PV/others) + Draft/Revise and review Standard Operating Procedures (SOPs) + Review calibration records and handle Impact Assessments in Regulatory Asset Manager + Identify gaps and improve processes + Manage protocol approvals in eDMS + Provide quality guidance to departments to fulfill regulatory and process requirements + Support various departments in achieving their qualification/validation needs + Develop a good understanding of the manufacturing processes and equipment + Understand the regulatory requirements (ISO9001, ISO13485, CFR210/211, ISO 14001) + Initiate and manage Non-conformances, Change Control and CAPA processes + Participate/Perform Root Cause Analysis + Assess risks in process/product and propose mitigation steps (ISO14971) **Qualifications/Requirements** **:** + cGMP background/understanding is critical for this role + Background in life sciences is preferred + Analytical thinking required to plan validations and analyze outcomes + Cleaning Validation and Computer System Validation experience is a great add-on + Ability to work in team and independently is important + Engaging with cross-functional groups to meet project goals + Good communication skillsetis key **Education and Experience:** + Bachelor's degree in a science or engineering discipline with a minimum of 1-5 years’ experience in qualification/ validation. + Experience in equipment qualification and validation process **Knowledge, Skills, and Abilities:** + Knowledge of process equipment, such as bioreactors, chromatography systems, CIP, and autoclave + Knowledge of biological process, such as fermentation, protein purification + Experience with fill and finish of lyophilized materials + Experience with cGMP manufacturing and clean utilities, such as clean steam, clean air, and WFI systems + Knowledge of cGMP manufacturing regulations for the FDA, EU and other countries as required + Assist in commissioning new buildings + Software validation experience + Understanding of equipment User Requirements/Risk Assessments + Attention to detail required to determine adequacy of testing results + Excellent computer skills **Why Join Bio-Techne:** **We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.** **We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.** **We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.** **We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.** **We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.** **We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.** **Bio-Techne is an E-Verify Employer in the United States.** **All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.** **To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.** Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.