QA Validation Engineer

Job Title:
Quality Engineering and Validation Consultant - CGT QA

Summary:
This onsite role (Monday-Friday) supports GMP activities for clinical and commercial Drug Product manufacturing. Reporting to the Associate Director of GMP Quality - Cell & Gene, the consultant provides expert quality assurance and compliance oversight.

Key Competencies

Leadership:

• Team collaboration
• Conflict resolution
• Results-oriented

Technical Skills:

• Thrives in fast-paced environments
• Cross-functional collaboration
• Strong communication across levels
• Critical thinking and problem-solving
• Risk-based decision-making
• Detail-oriented

Responsibilities

• Provide QA oversight for Cell & Gene Therapy operations and capital projects
• Support GMP manufacturing, validation, labs, materials management, and engineering
• Review change controls, protocols, risk assessments, investigations, and CAPAs
• Identify and communicate GMP risks and gaps
• Oversee calibrations, PMs, eCRs, work orders, and instrument qualifications
• Approve trending programs for equipment, facilities, and utilities
• Support environmental monitoring, routine testing, and control systems (BMS/EMS, pest control)

Qualifications

• QA experience in GMP manufacturing and capital projects
• Aseptic processing expertise
• Skilled in investigations, RCA, and CAPA
• Familiar with Veeva, Nuvolo, Viewlinc
• Master's degree + 3-5 years experience, or Bachelor's + 8 years, or equivalent background

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com