Senior Engineer, QA Operations Technology Transfer

Position Overview

The Senior Engineer, QA Operations Technology Transfer 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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

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: Development and approval of TT Gap assessment(s)

• Oversight of New Product Introduction (including Change Management mechanisms, as applicable)

• Approval of Process Flow Diagram(s) and Process Controls Document(s), as applicable

• Supports and approves of creation of new manufacturing documents in support of TT

• Supports and approves of process validation protocols and documentation (PPQ, process-specific cleaning plans, etc.)

• 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.

Knowledge, Skills, and Abilities

• Ability to work in a highly regulated environment and follow regulatory requirements and Good Manufacturing Practices (GMP).
• Ability to manage multiple assignments while meeting timelines in a GMP environment.
• High level of familiarity/understanding of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and/or validation methodologies.
• Advanced ability to work in a collaborative team environment and act as SME for tasks associated to their role.
• Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work.
• Ability to perform tasks such as SOP creation, program development, training curricula to deliver on operational and inspection readiness goals.
• Excellent organizational and critical thinking skills.
• Excellent communication skills (written and oral) to collaborate effectively with peers, department management and cross-functional peers.
• Understanding of Data Integrity, and application of 21 CFR Part 820 and Part 11.
• Occasional opportunity for International and/or Domestic travel may be available.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• 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 Qualifications

• Working knowledge and experience with Smartsheet, Trackwise, MasterControl, Veeva and/or Kneat validation software.

• Understanding of one or more of the following processes:

• 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.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• Ability to ascend or descend ladders, scaffolding, ramps, etc…
• Ability to stand for prolonged periods of time for up to 30 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.
• Ability to conduct work that includes moving objects up to 10 pounds.

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.

• LI-Onsite

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).