Quality Assurance Specialist, Validation

About the Company

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. Holly Springs combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Responsibilities

• Performs a role within the QA team for the development of documents, processes, and procedures for the Validation program
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities, and equipment are first validated and then maintained in a validated state
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities, and equipment
• Generates, reviews, and approves QA documentation, procedures, and processes for QA support of manufacturing operations in a cGMP regulated facility
• Ensures project and operational quality objectives are met within desired timelines
• Provides manufacturing (Clean Room) shop floor support for issue resolution, as needed
• Participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections
• Must be flexible to support a 24/7 manufacturing facility
• Performs other duties, as assigned

Requirements

• Bachelor’s degree in Life Sciences or Engineering with 2 years of applicable industry experience OR Master’s degree in Life Sciences or Engineering with no previous experience
• 1-3 years of experience working in a GMP regulated environment
• Experience in Validation and/or Quality oversight, in an FDA regulated facility

Preferred Qualifications

• Working knowledge and experience with ASTM E2500, Smartsheets, Trackwise, Veeva, and Kneat validation software
• Familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
• Understanding of Drug Substance, Drug Product and/or Finished Goods manufacturing processes
• Experience with startup projects or initiatives
• Training and/or familiarity with Quality Risk Management principles

Working Conditions & Physical Requirements

• May work in an environment which requires respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• May work in an environment operating a motor vehicle or Powered Industrial Truck
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color