Principal QA Validation Engineer

FUJIFILM Holdings America Corporation; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Cellular Dynamics, Inc. is seeking an expert in validation engineering to apply qualification and validation principles to GMP manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations and industry standards.

You will perform quality oversight of all validation for GMP including equipment, facility and utility systems and drug product manufacturing processes.

Qualifications

• Bachelor's degree in a relevant field; advanced degree preferred.
• 12+ years of experience in validation engineering with progression in responsibilities.
• Demonstrated organizational, problem solving, decision-making, communication and influencing skills.
• Detailed focused with strong MS Office writing and communication skills.

Responsibilities

• Design and develop validation plans with cross-functional teams.
• Generate IQ/OQ/PQ validation protocols for equipment, utilities, and systems.
• Develop validation strategy for IT/software systems ensuring data integrity.
• Write and review SOPs, protocols, reports, and validation master plans.
• Perform risk assessments and plan validation activities accordingly.
• Train end users on validation policies and requirements.

Skills

Validation engineering

Cross-functional collaboration

Regulatory compliance

Quality systems

Documentation review

Education

Bachelor's degree in a relevant field

Advanced degree preferred

Job description

Position Overview

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.

Company Overview

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

Job Description

Essential 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.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).