Principal QA Validation Engineer

FUJIFILM Cellular Dynamics, Inc. is seeking an expert in validation engineering who will apply knowledge of qualification and validation principles to manufacturing processes, quality systems, engineering design fundamentals, regulatory authority expectations and industry standards, as well as review and approve relevant documents. You will perform quality oversight of all validation for GMP including equipment, facility and utility systems, information technology, computerized systems, drug product manufacturing processes and methods.

At FUJIFILM Cellular Dynamics, we’re unlocking the power of human cells to change lives.

Using revolutionary induced pluripotent stem cell (iPSC) technology, we drive advancements in drug discovery, disease modeling, cell therapy, research tools, and cell therapy manufacturing.

Our mission is deeply meaningful, and we’re looking for bold innovators to join us.

At FUJIFILM Cellular Dynamics, you’ll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs.

If you’re ready to do work that makes a real impact and propels healthcare forward, this is your chance to be part of something extraordinary for science, patients, and yourself.

Our headquarters is in Madison, Wisconsin, a dynamic city celebrated for its lakes, parks, cultural richness, biotech leadership, and access to world-class academia.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging.

We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

• Provide validation focused design and development by engaging with cross-functional teams to define requirements, design, verification and validation plan and strategies.
• Serve as a best practices/quality resource on highly significant matters relating to policies, programs, capabilities, and long-range goals and objectives.
• Lead sub streams or participate in cross-functional project teams to solve complex problems by using analytical thinking, tools and judgment to identify innovative solutions
• Lead problem solving of complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including cross-functional impact, exercising sound judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional teams.