QA Engineer, Digital Technologies - Validation & Compliance

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Smartsheet and Kneat experience

Job summary

FUJIFILM Biotechnologies is seeking a QA Engineer, Digital Technologies to partner in the quality oversight of IT and automation systems. You will guide validation programs, assess risk, and ensure lifecycle documentation is complete for manufacturing operations.

The role requires collaboration with global teams, strong English communication, and deep knowledge of cGMP, FDA expectations, and data integrity. Travel may be possible as projects mature.

Qualifications

• Experience in Validation, cGMP manufacturing operations and/or Quality oversight.
• Familiarity with FDA regulations and data integrity expectations.
• Ability to assess risk and approve validation lifecycle documents.
• Experience with IT/OT systems and QS governance in biotech.

Responsibilities

• Partner in quality oversight of IT and OT systems from validation through operation.
• Provide QA oversight of project deliverables per governing DT processes.
• Assess impact of system changes and maintain validated state.
• Approve lifecycle docs, risk assessments, specs, and validation plans.
• Develop and approve QA procedures for validation approaches.
• Support regulatory inspections and cross-site process alignment.
• Ensure timelines meet quality objectives and drive continuous improvement.
• Collaborate with global teams to streamline processes.

Skills

Collaboration

English fluency

Quality risk mgmt

GMP knowledge

Validation experience

cGMP compliance

Data integrity

Regulatory knowledge

Project coordination

Education

Bachelor's in related science

Master's in related science

PhD (1+ years?)

Tools

Smartsheet

Kneat

DeltaV DCS

DeltaV MES

PAS-X

Octoplant

VDS

PI System

Job description

FUJIFILM Biotechnologies is seeking a QA Engineer, Digital Technologies to partner in the quality oversight of IT and automation systems. You will guide validation programs, assess risk, and ensure lifecycle documentation is complete for manufacturing operations.

The role requires collaboration with global teams, strong English communication, and deep knowledge of cGMP, FDA expectations, and data integrity. Travel may be possible as projects mature.