Sr. Upstream Process Engineer

Overview

The work we do at FujiFilm Diosynth Biotechnologies (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 state-of-the-art facility is located in Holly Springs, North Carolina, United States.

We are looking for a dedicated, result-oriented Senior Process Engineer I to join our Process Engineering team with a focus on upstream process equipment. As a Senior Engineer I, you will own the engineering responsibilities for the assigned equipment, deliver equipment packages on time and within budget, and work with CQV and the turnover team to ensure the equipment is ready for the first process. As the site moves into operations circa 2025, this position is planned for transition to a Process Engineering role in upstream. 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

MAJOR ACTIVITIES, ACCOUNTABILITIES & RESPONSIBILITIES:

Own Engineering responsibilities for assigned equipment throughout its lifecycle, from design through retire.

Deliver equipment packages on-time, within budget, and meeting technical and quality specifications.

Work with project EPCM and Global Fujifilm Diosynth Biotechnologies subject matter expert network to ensure designs align with the Company strategy.

Continuously seek to optimize the manufacturing processes & equipment to ensure effective use of capacity and minimize costs.

Establish and execute systems and procedures to enable proactive equipment monitoring, analysis, and reporting.

Charter and execute continuous improvement projects, in partnership with manufacturing where applicable, to improve manufacturability, reliability, yield and cost.

Provide technical support for manufacturing investigations and deviations, change controls and CAPA’s.

Author and/or review technical documentation

REQUIRED/PREFERRED EDUCATION AND EXPERIENCE:

Required for Senior Process Engineer I:

BS Engineering and minimum 8 years of experience or MS Engineering and minimum 6 years of experience

Prior experience with mammalian cell culture processes is required.

Working proficiency in multiple process areas is helpful.

Working proficiency in applicable codes and standards

Ability to travel nationally and internationally when projects require

Preferred for all levels:

Knowledge of cGMP regulations and guidance documents

Working proficiency with applicable FDA / EMA regulations

SPECIFIC SKILLS:

Coachable, able to receive performance feedback and respond in a positive manner.

Comprehend and markup P&ID drawings, Isometric drawings, and other technical documents.

GENERAL SKILLS FOR ALL FDBN POSITIONS:

Able to communicate effectively in English, both verbally and in writing

Always observe safety precautions and regulations in all areas where duties are performed

Excellent communication and interpersonal skills

Possess a positive roll-up-the-sleeves attitude and optimistic outlook

Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others

Excellent organizational and time management skills with ability to set own priorities in a timely manner

High degree of flexibility and adaptability

Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

Must be able to work as needed to meet tight deadlines and at peak periods

Self-motivated and organized critical thinker with solid interpersonal and business communication skills

Demonstrated ability to work in a cross functional team

Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements

Responsible for reporting all safety hazards and potential unsafe working conditions

Ensures FDBN or other required trainings/certifications are up to date

Represents the organization in a positive and professional manner

Reports to work on time and as scheduled

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 FDBN_PNC@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.