Senior QA Validation Engineer - GMP Systems & IT

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

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.