Head of Engineering Technology

Location
Holly Springs, NC
Posted
May 21, 2021
Ref
2021-15003
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

We are looking for a Head of Engineering Technology to manage our Engineering Science department in North Carolina. As Head of Engineering Technology, you will be responsible for the Site Master Plan (SMP) and technical leadership in the assessment and process design / fits for new equipment, facility and operational capabilities. In addition, you will drive engineering studies and provide expertise and drive implementation of improvements in DSM, DP & FGM.

As the Head of Engineering Technology, you will ensure that assigned deliverables are completed on schedule and within budget. In this role you will be managing the Engineering Science staff by developing department vision and strategy and performs other duties as required in support of department, functional and company goals.

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 FDB 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.

 

We are looking for someone with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization focusing on growth, people and a steep learning curve.

 

As the Head of Engineering Technology, you will:

 

Job Responsibilities

  • Management responsibility of Engineering Science staff.
  • Manage Site Master Plan (SMP).
  • Provide findings and data to senior management.
  • Departmental budget adherence
  • Process management of safety incidents investigation
  • Manage assessments and feasibility studies for prospective new and expanded capabilities for equipment, manufacturing and other requirements.
  • Responsible for technical leadership in the assessment and process design / fits for new equipment, facility and operational capabilities.
  • Represents Engineering Science as a first point of contact on technical assessments and engineering studies.
  • 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.
  • Expert in the process equipment and technologies within Engineering

Requirements

  • Bachelor's degree required in Biochemical or Chemical Engineering
  • Twelve years in pharmaceutical or biotech manufacturing or engineering environment.
  • Provides expertise and advice to guide the activities of a major project or activity
  • Solid experience with Drug Substance (DS) process equipment and unit operations.
  • Proven ability to represent group or company with external partners or organizations.
  • Advanced knowledge and application of GMP and EMEA regulations
  • Viewed as expert in the process equipment and technologies within Engineering.
  • 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
  • Excellent oral and written communications skills in English
  • #Li-Diosynth

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.