QA Engineer, Digital Technologies

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

The QA Engineer, Digital Technologies is responsible for partnering in the Quality oversight of IT and Automation (OT) systems and provides oversight of validation program execution for these systems. This role collaborates within the Digital Technologies (DT) Quality team as well as with other project teams, and with QA departments at other sites with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

What You’ll Do

• During the project phase, partners in the Quality oversight of IT and Automation (OT) systems through to operational readiness, as well as provide oversight of validation program execution for these systems.
• Provides QA oversight and support of project deliverables in accordance with governing processes, and procedures for the DT program.
• Assesses the impact of system and process modifications and maintain oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, 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 IT and Automation (OT) systems.
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Ensures project and operational quality objectives are met within desired timelines.
• Collaborates and aligns with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Develops and supports start up activities into operations as the project matures, such as system optimization or improvement initiatives and supporting regulatory agency and third-party inspections.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Excellent oral and written communications skills and fluency in English.
• Training and/or familiarity with Quality Risk Management principles.
• Familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to be agile and flexible to meet internal and external needs.
• Knowledge and application of cGMP compliance and other related regulations.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11/Annex 11.
• Occasional opportunity for International and/or Domestic travel may be available.

Minimum Qualifications

• Bachelor’s in related science field with 5+ years applicable experience; OR,
• Masters in related science field. With 3+ years applicable experience; OR,
• PhD and 1+ years applicable experience.
• 3+ years of experience working in a GMP regulated environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
• Experience and working knowledge of ASTM E2500, CSV/CSA, and ALCOA+.

Preferred Qualifications

• 5+ years of experience in a GMP quality assurance (QA) role with oversight of Automation GxP systems validation and lifecycle.
• Prior experience with Smartsheet and electronic validation software (e.g. Kneat).
• Previous experience with the following processes preferred: Manufacturing Automation (e.g., DeltaV DCS, DeltaV MES, PAS-X, Octoplant, VDS, ICE, PI System).
• Prior experience and understanding of Data Integrity activities (e.g., Data Integrity Assessment, Audit Trail Review).