This job has expired

You will need to login before you can apply for a job.

Head of Engineering & Project Execution

Employer
FUJIFILM Diosynth Biotechnologies
Location
Holly Springs, NC
Start date
Oct 2, 2022
You need to sign in or create an account to save a job.

Job Details

The Head of Engineering & Project Execution will be responsible for the establishment of the entire production facility covering DSM and DPFG in the Project.  This exciting and unique project will invest over $2B and recruit over 725 employees through 2025, establishing end to end manufacturing capacity and enabling delivery of life-saving medication to patients.

The Head of Engineering & Project Execution is the leader in the establishment of the facility with responsibility of getting the facility ready with all relevant aspects (process equipment, buildings etc.), within budget and on time. This position will have a profound impact on the success of our site.  You will be responsible for securing the facility is structured, designed, engineered, and constructed in a way that lives up to the expectation of future operations.

The position will oversee all engineering areas and collaborate closely with internal (FUJIFILM, FUJIFILM Diosynth Biotechnologies global) as well as external (local, regional and federal level and suppliers) stakeholders.

External US

RESPONSIBILITIES:




  • Lead the establishment of our new production facility in Holly Springs with oversight of project delivery which includes the initial engineering, equipment procurement, sub-contract procurement to build the facility and then accountability for the automation and CQV efforts to result in a fully functional large-scale monoclonal antibody Drug Substance and Drug Product facility

  • Manage engineering areas across functions such as Drug Substance Manufacturing (DSM), Drug Products & Finished Goods (DPFG), IT & Automation, CUB/Warehouse/Admin, Engineering Management, Project Services, and Commissioning, Qualification & Validation (CQV)

  • Manage the construction management function and serve as a primary liaison between FDB and Engineering Procurement and Construction Manager partner.

  • Collaborate with internal and external stakeholders, ensuring project success and alignment on goals & objectives

  • Provide cGMP compliant processes and facilities that meet FDA regulations and requirements


 


REQUIREMENTS:



  • BA/BS Degree in Physical, Chemical or Biological Science, Technical Engineering or equivalent is required; Master's Degree is preferred

  • Minimum of 15 years' pharmaceutical & biotechnology industry experience is required

  • Minimum 10 years' experience working in project delivery for pharmaceutical manufacturing facility build projects is required

  • Large project leadership experience including directing site expansions and establishing greenfield manufacturing facilities

  • Experience managing project financials including large scale capital projects

  • Excellent problem-solving skills and an optimistic, solution-driven mindset

  • Ability to influence and lead cross-functionally


 


 


FDBN 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.


 


FDBN 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. If an accommodation to the application process is needed, please email lena.lee@fujifilm.com.


 


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.

Company

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

FacebookTwitter

Find Us
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert