Validation Engineer I

Join us at the forefront of scientific discovery! At Bio-Rad Laboratories, you will participate in exciting new developments at the cutting-edge of science and technology. Our teams of dedicated professionals work together in an entrepreneurial atmosphere, providing a broad range of innovative tools and services to the clinical diagnostics and life science research markets. Bio-Rad was founded more than 40 years ago, and we are recognized as a world leader in science and research. Visit us at www.bio-rad.com

Provide strategic guidance regarding process validation and risk assessment to Bio-Rad QSD management and cross-functional teams. Provide sound, scientific solutions to complex problems, with respect to process validation, corporate, industry, and regulatory standards. Represent the process validation effort for process changes, including product transfers between departments. During process validation implementation the role of this position includes driving timelines, decision-making, managing process validation documentation, and/or review of relevant technical submissions and ensuring accuracy of our process validation packages and submissions.

Experience: Proficiency in US CFR's, US & GHTF's requirements and Guidelines for Validation & Related Quality Systems.

Skills: Ability to influence, lead, and collaborate with others. Ability to problem solve, address complex issues on a departmental level, and make policy decisions. An understanding of cGMPs and quality and regulatory systems, along with working knowledge of manufacturing process steps and quality control for in-vitro diagnostic product manufacturing. Requires familiarity with analytical techniques and experimental design used for process validation. Excellent communication skills and ability to diplomatically establish and enforce regulatory standards. Proficiency in Equipment, Utility, and Process Validation of In-Vitro Diagnostic Products or equivalents. Proficiency in Microsoft Word, Excel, Powerpoint, and Database applications.

Education: Minimum of 5 years relevant pharmaceutical/biotechnology experience. Holds B.S./B.A. degree in Chemistry, Biochemistry, Microbiology, Engineering, or a related life science.