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Sr. Engineer, QA Operations (Tech Transfer)FUJIFILM Holdings America Corporation • Holly Springs, North Carolina, United States
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Sr. Engineer, QA Operations (Tech Transfer)

FUJIFILM Holdings America Corporation
  • US
    Holly Springs, North Carolina, United States
  • US
    Holly Springs, North Carolina, United States
Jetzt Bewerben

Über

Position Overview The Sr. Engineer, Quality Assurance is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site.
This position is responsible for ensuring the quality and compliance of initial Technology Transfer (TT) activities and supporting the continuous improvement and ongoing success of the TT lifecycle.
This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.
Job Description What You’ll Do
Participates in establishing programs and systems to ensure all GxP requirements associated with TT activities are phase appropriate and are in compliance
Ensures TT process and interdependencies are defined and well understood, and leverage data and technology to drive compliance, efficiency, and monitoring
Ensures integration of TT process with other Quality Systems (Deviation/CAPA, Change Control, Validation)
Provides guidance and quality oversight of cGMP activities supporting all TT deliverables through a phase-based delivery model including:
a. Development and approval of TT Gap assessment(s)
b. Oversight of New Product Introduction (including Change Management mechanisms, as applicable)
c. Approval of Process Flow Diagram(s) and Process Controls Document(s), as applicable
d. Supports and approves of creation of new manufacturing documents in support of TT
e. Supports and approves of process validation protocols and documentation (PPQ, process-specific cleaning plans, etc.)
f. Supports and approves of new entries and records in support of TT (eBPR, BoM, etc.)
Provides status reports and quality metrics to support management review process
Partners with cross-functional teams to ensure TT milestones are competed on time and within specification
Provides input, review, and approval for complex / critical deviations, CAPAs, change controls or other quality records in support of TT; Serves as TT SME for QA with regulators, clients, and company management
Assists QA senior management with departmental needs and performs other duties, as assigned
Minimum Requirements:
Bachelor’s in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience OR
Master’s in Life Sciences or Engineering and 6+ years of applicable experience OR
PhD in Life Sciences or Engineering and 4+ years of applicable experience
Previous experience in Tech Transfer
4+ years of experience working in a GMP environment
Preferred Requirements:
Working knowledge and experience with Smartsheet, Trackwise, MasterControl, Veeva and/or Kneat validation software is a plus
Understanding of one or more of the following processes preferred:
cell culture/upstream processes
large scale recovery/downstream processes
aseptic processing
Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills.
Training and/or familiarity with Quality Risk Management principles preferred.
Working Conditions & Physical Requirements:
Will work in environment which may necessitate respiratory protection
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
Will work in environment operating a motor vehicle or Powered Industrial Truck
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
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  • Holly Springs, North Carolina, United States

Sprachkenntnisse

  • English
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