Position OverviewFUJIFILM 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.
Job DescriptionEssential Job Functions- 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.
- Generate validation protocols (IQ/OQ/PQ) of all site equipment including laboratory equipment, production equipment, utilities (as applicable) and other related systems in a Health Authority regulated environment.
- Generate validation strategy for OTS software and IT systems, ensuring compliance with data integrity expectations.
- Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Perform risk assessments for GMP systems as required and plan validation efforts according to risk.
- Train end users on validation policies and requirements to support GMP operations.
- Collaborate with clients and vendors to meet project and company objectives.
- Participate in audits and regulatory agency inspections for Validation.
- Serve as subject matter expert in qualification and validation.
- Troubleshoot and coordinate failure investigations for manufacturing and laboratory equipment.
- Assist with vendor communications and maintenance/repair scheduling.
- Resolve deviations and non-conformances reported during validation/qualification.
- Assist with engineering studies and investigations in other departments and perform any additional responsibilities as requested or assigned.
- Other duties as assigned.
Qualifications- Bachelor's degree in a relevant field; advanced degree preferred.
- A minimum of twelve (12) years of relevant experience in technical and/or quality validation engineering with demonstrated progression in responsibilities.
- Demonstrated organizational; problem solving; decision-making; communication (oral and written); and influencing skills - dealing with diverse stakeholders.
- Detailed focused, with demonstrated writing and communication skills using MS Office.
Physical Requirements:- Able to work at a computer for extended periods of time.
- Able to wear standard laboratory PPE.
