QA Engineer, Digital Technologies

American Society for Quality; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies seeks a QA Engineer, Digital Technologies to partner in quality oversight of IT and OT systems and to oversee validation program execution across projects.

Collaborating with the DT Quality team and other site QA groups, you will ensure policy consistency, manage day-to-day QA activities, and support regulatory inspections as the project matures.

Qualifications

• Bachelor's in related science field with 5+ years applicable experience; OR, Masters 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+.

Responsibilities

• Partner in the Quality oversight of IT and Automation (OT) systems through to operational readiness.
• Provide QA oversight of project deliverables per governing processes for the DT program.
• Assess impact of system modifications and oversee change management to maintain validated state through startup and commercial operation.
• Provide oversight and approval of system lifecycle documentation, including risk assessments, specifications, and validation plans/reports.
• Generate, review, and approve QA procedures for the validation approach and lifecycle documents.
• Generate, review, and approve QA documentation and processes for operational readiness and QA support of manufacturing operations.
• Ensure project and operational quality objectives are met within timelines.
• Collaborate with other FUJIFILM Biotechnologies sites to streamline processes.
• Develop and support startup activities into operations, such as system optimization and inspections.
• Perform other duties, as assigned.

Skills

Communication

Quality Risk Mgmt

GxP compliance

cGMP validation

Data Integrity

IT/OT validation

Cross-functional teamwork

Education

Bachelor's degree in related science

Master's degree in related science

PhD in related science

Tools

Smartsheet

Kneat

DeltaV DCS

DeltaV MES

PAS-X

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: Strong experience with manufacturing automation (e.g., DeltaV DCS, DeltaV MES, PAS-X, Octoplant, VDS, ICE, PI System), familiarity with IT systems and/or IT Infrastructure.
• Prior experience and understanding of Data Integrity activities (e.g., Data Integrity Assessment, Audit Trail Review).