Senior QA Validation Lead – GMP & IT Systems

FUJIFILM Cellular Dynamics, Inc; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Cellular Dynamics, Inc. in Madison, WI seeks an expert in validation engineering to apply qualification and validation principles to manufacturing processes, quality systems, and regulatory expectations.

The role oversees validation for GMP equipment, facilities, utilities, IT systems, and drug product processes. The candidate will generate IQ/OQ/PQ protocols, SOPs, and validation master plans, lead risk assessments, train end users, and coordinate audits and inspections to ensure data

Qualifications

• Bachelor's degree in a relevant field; advanced degree preferred.
• Minimum 12 years of experience in technical and/or quality validation.
• Strong organizational, problem-solving and communication skills.

Responsibilities

• Define requirements and develop validation plans with cross-functional teams.
• Lead IQ/OQ/PQ validation protocols for equipment, facilities and IT systems.
• Review SOPs, protocols, reports and validation master plans for GMP systems.
• Perform risk assessments for GMP systems and plan validation activities.
• Train end users on validation policies and requirements.
• Coordinate audits and regulatory inspections for validation activities.

Skills

Validation engineering

Quality systems

Regulatory compliance

Education

Bachelor's degree in a relevant field

Advanced degree preferred

Job description

FUJIFILM Cellular Dynamics, Inc. in Madison, WI seeks an expert in validation engineering to apply qualification and validation principles to manufacturing processes, quality systems, and regulatory expectations.

The role oversees validation for GMP equipment, facilities, utilities, IT systems, and drug product processes. The candidate will generate IQ/OQ/PQ protocols, SOPs, and validation master plans, lead risk assessments, train end users, and coordinate audits and inspections to ensure data