Drug Substance Manufacturing Downstream Process Engineer

Job description

The Downstream Equipment Engineer will ensure that the downstream process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and 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.

We are looking for someone with positive energy, entrepreneurship, and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference.

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 state-of-the-art facility is located in Holly Springs, North Carolina, United States.

We offer the possibility of playing a central role in the Drug Substance Manufacturing Downstream Process Equipment work package in a $2 billion global project. We are looking for expertise in downstream process engineering with experience in production of monoclonal antibodies and expertise in anion and cation chromatography, viral deduction and viral filtration, tangential flow filtration and/or ultra-filtration diafiltration.

You, as the Downstream Equipment Engineer, will ensure that the downstream process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and 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.

We are looking for someone with positive energy, entrepreneurship, and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference.

Job Responsibilities

• Part of the process equipment team throughout the project being the main contact to the Engineering Partner / Construction Manager (EPCM) provider
• 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 & Approve PI&Ds and other process design documents
• Writing URSs, Functional Specifications, and applicable process equipment design documents
• Review and approve vendor submittals including material of construction, isometrics
• Participate in equipment vendor FATs, SATs, and on-site commissioning
• Lead and work with cross-functional groups to organize equipment startup and transfer into GMP manufacturing
• Lead project change controls when necessary to ensure proper operation of equipment

Requirements

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

• Bachelor or Master in Physical, Chemical or Biological Science, Technical Engineering or equivalent
• 8-15+ years' experience from similar role in large pharma/biotech projects.
• Experience in a cGMP facility or working with FDA regulations.
• Good 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.