Validation QA Engineer, Life Sciences (GMP)

FUJIFILM Healthcare Americas Corporation

Holly Springs (NC)

On-site

USD 110,000 - 140,000

Full time

2 hours ago

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Job summary

FUJIFILM Biotechnologies is hiring a QA Engineer, Validation in Holly Springs, NC to drive quality oversight for commissioning and qualification processes. You will review and approve validation activities and maintain validated state of systems, equipment, and processes.

The role requires collaboration across functions, readiness for travel, and support during regulatory inspections. Ideal candidates have a life sciences or engineering background with GMP experience and strong documentation

Qualifications

Bachelor''s degree with 5+ years in a GMP-regulated environment.
Experience in Validation and/or Quality oversight in FDA-regulated facility.

Responsibilities

SME role for development of documents, processes, and procedures for Validation.
Assess impact of system and process modifications; maintain validated state.
Provide oversight and approval of lifecycle documentation (risk, requirements, specs, validation plans).
Generate, review, and approve QA procedures for validation approach and lifecycle documents.
QA support of manufacturing operations in a cgmp facility; ensure timelines.
Support 24/7 manufacturing facility and regulatory inspections.