Validation QA Engineer - Drive GMP Excellence in Biotech

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 90,000 - 135,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QA Engineer, Validation to drive quality oversight for commissioning, qualification, and validation lifecycle activities. You will review and approve validation documents and ensure systems remain in a validated state.

Strong communication and collaboration with global teams, knowledge of cGMP, regulatory expectations, and a willingness to support 24/7 manufacturing are required.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 5 years of applicable industry experience; OR, Master’s degree with 3 years; OR, PhD with 1 year.
• 3+ years of experience working in a GMP regulated environment.
• Experience in Validation and/or Quality oversight, in an FDA regulated facility.
• Preferred: Working knowledge of ASTM E2500, Smartsheets, Trackwise, Veeva, Kneat validation software; understanding of GAMP5, Data Integrity, and 21 CFR Part 820 and Part 11.

Responsibilities

• Performs a subject matter expert (SME) 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 cGMP regulated facility.
• Ensures project and operational quality objectives are met within desired timelines.
• Manufacturing (Clean Room) shop floor support for issue resolution, as needed.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Must be flexible to support 24/7 manufacturing facility.
• Performs other duties, as assigned.

Skills

Communication

English fluency

Problem solving

Time management

Collaboration

Education

Bachelor’s degree in Life Sciences or Engineering

Master’s degree in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

ASTM E2500

Smartsheets

Trackwise

Veeva

Kneat validation software

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QA Engineer, Validation to drive quality oversight for commissioning, qualification, and validation lifecycle activities. You will review and approve validation documents and ensure systems remain in a validated state.

Strong communication and collaboration with global teams, knowledge of cGMP, regulatory expectations, and a willingness to support 24/7 manufacturing are required.