Position OverviewThe 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 DescriptionWhat 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
Performs other duties, as assigned
Minimum Requirements:- Bachelor's in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience OR
- Masters 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 X No Yes
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
- Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
- Ability to discern audible cues. No X Yes
- Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
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.
