Senior QA Validation Engineer - GMP & IT Systems

FUJIFILM Cellular Dynamics, Inc; Madison (WI); On-site; USD 140,000 - 190,000; Full time

Job summary

FUJIFILM Cellular Dynamics, Inc. is seeking an expert in validation engineering to apply qualification and validation principles to manufacturing processes and regulatory expectations.

You will oversee validation across GMP equipment, facilities, utilities, and IT systems, and lead cross-functional teams to ensure data integrity and compliant operations. The role requires 12+ years in validation engineering, a relevant bachelor’s degree (advanced degree preferred), and strong communication,

Qualifications

• Bachelor's degree in a relevant field; advanced degree preferred.
• Minimum 12 years of relevant experience in validation engineering.
• Strong organizational, problem-solving and communication skills.
• Ability to interact with diverse stakeholders.

Responsibilities

• Develop and qualify validation strategies for GMP equipment and systems.
• Lead IQ/OQ/PQ protocols for site equipment.
• Review SOPs, reports, and validation master plans.
• Collaborate with cross-functional teams and auditors.
• Provide training on validation policies.

Skills

Organizational

Problem solving

Decision making

Communication

Influencing

Education

Bachelor's degree

Tools

MS Office

Job description

FUJIFILM Cellular Dynamics, Inc. is seeking an expert in validation engineering to apply qualification and validation principles to manufacturing processes and regulatory expectations.

You will oversee validation across GMP equipment, facilities, utilities, and IT systems, and lead cross-functional teams to ensure data integrity and compliant operations. The role requires 12+ years in validation engineering, a relevant bachelor’s degree (advanced degree preferred), and strong communication,