DPFG Visual Inspection SME

Location
Holly Springs, NC
Posted
Sep 29, 2021
Ref
2021-15674
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

As the Visual Inspection SME, your main responsibility is to lead and drive the deliverables for establishing manual and automated visual inspection capabilities and act as a strong contributor to the qualification strategy and plan for visual inspection within generic test sets, operator qualification, knapp tests etc. Additional responsibility includes providing SME support for DI issues during commercial and clinical manufacturing as processes are established.

External US

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

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 solutions to 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 site is to be located in Holly Springs, North Carolina, United States.

We are looking for a Visual Inspection Scientist/ Subject Matter Expert (SME) to join our Manufacturing Sciences (MS) organization within the area of Drug Product and Finish Goods Manufacturing (DPFG), who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America.

As the Visual Inspection SME, your main responsibility is to lead and drive the deliverables for establishing manual and automated visual inspection capabilities and act as a strong contributor to the qualification strategy and plan for visual inspection within generic test sets, operator qualification, knapp tests etc. Additional responsibility includes providing SME support for DI issues during commercial and clinical manufacturing as processes are established.

We offer you the possibility to play a central part in a $2 billion global project leveraging your existing experience within formulations, equipment preparation, the filling process and fill/pack machinery.

As the Visual Inspection Process SME you must be able to, proactively facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects.

 

The role will be reporting to the DPFG Head of Process.

We are looking for a SME with positive energy, entrepreneurship, and courage to empower and inspire others while utilize your extensive knowledge and knowhow. You will join an organization focusing on growth, people, and a steep learning curve as well as a diverse workplace with people driven to make a difference.

Job Responsibilities

  • Lead and Serve as the Automated Visual Inspection (AVI) equipment Subject Matter Expert (SME) in the development, evaluation, enhancement, and validation of critical process parameters in support of new, transferred and existing product lines.
  • Has the required process and technical depth to represent the Company in discussions around AVI with customers and / or auditors.
  • Drive experimental development towards most reliable process parameters (ranges) ensuring high uptime while minimizing possible product loss.
  • Driving Tech Transfer work packages when transferring new products to the new facility in North Carolina.
  • Provide SME support for issues and investigations during commercial and clinical manufacturing when manufacturing processes are established
  • Work closely with the team to develop and confirm Critical and Key Process Parameters needed for Equipment and Process Validation.
  • Drive continuous improvement of the inspection process.
  • Support the harmonization of drug product manufacturing process technologies across Fujifilm, both in the US and globally.
  • Participate in customer meetings with new partners and products when relevant
  • Participate in relevant conferences, industry forums and trade fairs for competence development with possibility of representing FDBU in the wider industry through network building
  • Participate in formulation development, visual inspection process development, stability, E/L and scale-up
  • Participate in investigations for process and produced related issues in formulation, pooling, sterile filtration, VHP process, glove management, automated and manual visual inspection etc.
  • Secure on time delivery and in right quality from both Fujifilm and EPCM provider
  • Develop and align plans, and in due time propose mitigations if plans are not met
  • Review Process Flow Diagrams (PFDs), P&IDs, and other process design documents.
  • Author new User Requirement Specification (URS) documents and manage them through their SDLC.

Requirements

We are looking for a candidate with the following background and skill sets:

Preferred Requirements

  • 8+ years of experience from similar role in large projects from conceptual design phase to operations
  • Minimum 5+ years of industrial experience from pharmaceutical industry
  • Technical expertise in cGMP best practices, such as PDA Technical Reports 22, 26, 60, and 79.
  • Leadership experience within cell culture and aseptic manufacturing facilities

Basic Requirements

  • Bachelor's or Master's degree in Physical, Chemical or Biological Science, Technical Engineering or equivalent
  • Process knowledge within Drug Product & Finish Goods Manufacturing
  • Experience in a cGMP facility or working with FDA regulations.
  • Excellent communication skills and fluency in English

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU 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.

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.