Senior QA Engineer — CQV & Validation Expert

Merck & Co.; 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 provide QA oversight for CQV activities and maintain validated states of systems and equipment. The role includes reviewing validation documents, risk assessments, and change management to ensure regulatory readiness.

You will mentor teammates, support regulatory inspections, and collaborate across departments to drive on-time delivery of quality objectives in a 24/7 manufacturing environment.

Qualifications

• Bachelor's degree in Life Sciences or Engineering with 8+ years of applicable industry experience.
• Master's degree in Life Sciences or Engineering with 6+ years of applicable industry experience.
• PhD in Life Sciences or Engineering with 4+ years of applicable industry experience.
• 4+ years of experience working in a GMP regulated environment.
• Experience in Commissioning, Qualification, and Validation (CQV) and Quality oversight, in an FDA regulated facility.

Responsibilities

• Serves as QA CQV SME with regulators, clients, and company management.
• Oversees change management processes to ensure facilities, utilities and equipment are validated and maintained.
• Oversees and approves system and process documentation, including validation plans and reports.
• Develops, reviews, and approves QA procedures for validation approaches and lifecycle documents.
• Ensures completion of project and operational quality objectives within timelines.
• Provides manufacturing (Clean Room) shop floor support for issue resolution.
• Participates in optimization or improvement initiatives.
• Supports regulatory agencies and third-party inspections.
• Mentors less experienced team members with QA validation guidance.

Skills

CQV Expertise

Regulatory Compliance

GMP Knowledge

Documentation Proficiency

Cross-functional Collaboration

Risk Assessment

Data Integrity

Project Management

Technical Writing

Validation Lifecycle

Education

Bachelor's degree in Life Sciences or Engineering

Master's degree in Life Sciences or Engineering

PhD in Life Sciences or Engineering

4+ years GMP experience

Tools

ASTM E2500

Smartsheets

TrackWise

Veeva

Kneat

Job description

Fujifilm Biotechnologies in Holly Springs, NC seeks a Senior QA Engineer, Validation to provide QA oversight for CQV activities and maintain validated states of systems and equipment. The role includes reviewing validation documents, risk assessments, and change management to ensure regulatory readiness.

You will mentor teammates, support regulatory inspections, and collaborate across departments to drive on-time delivery of quality objectives in a 24/7 manufacturing environment.