Senior Process Engineer - Technology Lead

Location
Holly Springs, NC
Posted
May 21, 2021
Ref
2021-15004
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

We are looking for a dedicated, result-oriented Senior Process Engineer to join our Engineering Sciences team. As a Technology Lead, you will be providing engineering technical leadership, and primarily designs, and specify new equipment for all Drug Substance (DS) processing equipment and utilities on the site. You will be a subject matter expert in technical investigations and in the technology transfer of new products/processes. You will champion transformation of engineering, manufacturing and facility technologies, participate in industry forums and provide technical engineering expertise for new processing equipment installations and modifications to existing equipment.

We are looking for someone with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization focusing on growth, a steep learning curve and most importantly a focus on people and what you can bring to the table.

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 create 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 will be built within the vicinity of an existing Fujifilm site in the US.

 

As the Senior Process Engineer, you will:

 

Job Responsibilities

  • Manage assessments and feasibility studies for prospective new and expanded capabilities for equipment, manufacturing and other requirements.
  • Technical leadership in the assessment and process design / fits for new equipment, facility and operational capabilities.
  • Drive engineering studies to confirm process fit to plant for new processes and changes to existing processes
  • Provide expertise and advice to guide the activities of a major project or activity.
  • Actively identify gabs and suggest/drive implementation of improvements within the DS manufacturing areas.
  • Perform process simulation to optimize throughput and identify potential bottlenecks
  • Interaction with senior internal and external personnel on significant matters often requiring coordination between Organizational Units.
  • Provide regular updates to Sr. Leadership on strategic initiatives, key technical efforts, facility fits and investments
  • Expert in the process equipment and technologies within Engineering

Requirements

  • Master‘s or Bachelor's degree in a scientific or engineering subject with a minimum of 10 years related industry experience
  • Solid experience with Drug Substance (DS) process equipment and unit operations.
  • Knowledge of early phase equipment design and facility layouts
  • Knowledge with Drug Product (DP) and/or Finished Goods (FG) process equipment and unit operations would be beneficial but not a requirement.
  • Has achieved an advanced level of expertise and is capable of working on problem solving for a variety of different projects or assignments.
  • Collaborative attitude with the willingness to work with global peers toward company and department goals. Focused dedication with the willingness to do what it takes to get the job done.
  • Ability to lead large group meetings, including cross functional groups and external partners and organizations
  • Knowledge of GMP and EMEA/FDA regulations (or experience working in a similar highly regulated environment)
  • Excellent oral and written communications skills 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.