Senior QA Validation Engineer — CQV & GMP Expert

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior QA Engineer, Validation to lead CQV oversight for commissioning, qualification, and validation of facilities, utilities and equipment. Occasional travel may be available.

You will develop and approve validation plans, ensure data integrity and regulatory compliance (21 CFR Part 820/11), and mentor teammates to support inspections in a fast-paced, GMP environment.

Qualifications

• Bachelor’s or higher in Life Sciences/Engineering with GMP experience.
• Experience in CQV and Quality oversight in FDA-regulated facilities.
• Familiarity with validation lifecycle documents and risk assessments.

Responsibilities

• Serve as QA CQV SME with regulators, clients, and management.
• Review and approve validation plans, protocols, and reports.
• Ensure facilities, utilities and equipment stay in validated state.
• Support regulatory inspections and third-party audits.
• Mentor junior team members and provide technical guidance.

Skills

GMP compliance

CQV experience

Regulatory oversight

Data Integrity

Regulatory documentation

Project management

Communication

SOP development

Education

Bachelor’s degree in Life Sciences or Engineering

Master’s degree in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

TrackWise

Veeva

Kneat

Smartsheets

ASTM E2500

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior QA Engineer, Validation to lead CQV oversight for commissioning, qualification, and validation of facilities, utilities and equipment. Occasional travel may be available.

You will develop and approve validation plans, ensure data integrity and regulatory compliance (21 CFR Part 820/11), and mentor teammates to support inspections in a fast-paced, GMP environment.