QA Engineer, Drug Substance Manufacturing (12-Hr Shifts)

FUJIFILM; Holly Springs (NC); Presencial; USD 95.000 - 150.000; Jornada completa

Descripción de la vacante

FUJIFILM Biotechnologies, located in Holly Springs, NC, seeks a QA Engineer for Drug Substance Manufacturing Operations. The role provides QA oversight for DSM processes from project phase through startup to commercial operation, including change management and regulatory readiness. A 12-hour day shift (2-2-3) is required.

The team collaborates across FUJIFILM sites to optimize quality and compliance, ensuring cGMP adherence and readiness for inspections. Occasional travel may be available.

Formación

• BS/BA in Life Sciences or Engineering with 5+ years of applicable industry experience.
• MS in Life Sciences or Engineering with 3+ years of applicable experience.
• PhD in Life Sciences or Engineering with 1+ year of applicable experience.
• 3+ years of experience in a GMP regulated environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.

Responsabilidades

• Performs SME role within the QA team for DSM program documents, processes, and procedures.
• Assesses impact of system and process modifications and maintains change management oversight to ensure validated state from startup to commercial operation.
• Generates, reviews, and approves QA documentation for operational readiness and QA support of manufacturing operations in a cGMP facility.
• Ensures project and operational quality objectives are met within timelines.
• Collaborates with FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Participates in optimization initiatives and support regulatory inspections.

Conocimientos

Communication skills

English fluency

Time management

Critical thinking

Validation experience

GAMP5 knowledge

Data integrity

21 CFR Part 11

GMP knowledge

Team collaboration

Educación

BS/BA in Life Sciences or Engineering

MS in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Herramientas

ASTM E2500

Smartsheet

Trackwise

MasterControl

Kneat validation software

Descripción del empleo

FUJIFILM Biotechnologies, located in Holly Springs, NC, seeks a QA Engineer for Drug Substance Manufacturing Operations. The role provides QA oversight for DSM processes from project phase through startup to commercial operation, including change management and regulatory readiness. A 12-hour day shift (2-2-3) is required.

The team collaborates across FUJIFILM sites to optimize quality and compliance, ensuring cGMP adherence and readiness for inspections. Occasional travel may be available.