QA Engineer

2 weeks ago

Holly Springs, United States FUJIFILM Corporation Full time
Overview

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The QA Engineer will be responsible to partner 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. You will collaborate 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.

External US
  • During the project phase, the QA Engineer will be responsible to partner 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.
  • Provide QA oversight and support of project deliverables in accordance with governing processes, and procedures for the DT program.
  • Assess 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.
  • Provide 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.
  • Generate, review, and approve QA procedures for the validation approach and lifecycle documents for IT and Automation (OT) systems.
  • Generate, review, and approve QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
  • Ensure that project and operational quality objectives are met within desired timelines.
  • Collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency.
  • Develop and support start up activities into operations as the project matures, such as system optimization or improvement initiatives and supporting regulatory agency and third-party inspections.
  • Other duties as assigned.

Minimum Requirements:

  • BS/BA or equivalent and 6+ years applicable experience
  • Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
  • Working knowledge of ASTM E2500, CSV/CSA, and ALCOA+.
  • Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11/Annex 11

Preferred Requirements:

  • MS and 4+ years applicable experience
  • PhD and 2+ years applicable experience
  • A minimum of 6 years' experience in a GMP quality assurance (QA) role.
  • Prior experience with Smartsheet and electronic validation software (e.g. Kneat).
  • Understanding of one or more of the following processes preferred:
    • GxP systems
    • Serialization
    • Infrastructure (IT and/or OT related)
    • Manufacturing Execution Systems (MES)
    • Process Control Systems (PCS) and Building Management Systems (BMS)
    • PI Historian

PHYSICAL DEMANDS

  • Ability to stand for prolonged periods of time up to 30 minutes
  • Ability to sit for prolonged periods of time up to 120 minutes

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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