Do you have extensive experience with the management of large technical projects in a complex pharmaceutical environment? For the FUJIFILM Diosynth Biotechnologies Large Scale Business Unit we are looking for a Distinguished Engineer to develop and deploy a vision and future state for potential entry of new process operations, key evolving technologies, and Engineering Systems.

This SME role provides engineering technical leadership to develop and improve processes, optimize pharmaceutical processing equipment and plant utilities, and guidance on design and procedures for working in hazardous environments for Antibody Drug Conjugates.

The position provides subject matter expertise in technical investigations and in the technology transfer on new products/processes, leads continuous improvement and equipment and facility performance optimization efforts, and provides project engineering support as required for new processing equipment installations and modifications to existing equipment.

The Distinguished Engineer is a vital role to ensure that CapEx projects across the Large-Scale Business Unit are executed consistently, efficiently and in accordance with our project model, systems, guidelines, and standards. In this role you will assist in Antibody Drug Conjugates, process engineering and automation activities. You will ensure alignment on shared goals through collaboration with Holly Springs location, engaging with other sites and stakeholders as needed. 

Main Responsibilities

• Research, assess and evaluate innovative and creative technologies and solutions related to automation and process improvement for small and large molecule processes. This includes prospecting of new and expanded capabilities for equipment, processes and automated systems in FDB Antibody Drug Conjugates manufacturing and support facilities. Area of engineering can span across Drug Substance and Drug Product at large and small scales.
• Assuming Technical Project Leadership and/or support roles to support technical projects, e.g. with the purpose to:
• Develop and improve ADC processes and plant design
• Develop feasibility studies and conceptual briefs on major strategic projects
• Feasibility and "fit for purpose" assessments including selection processes of systems and equipment
• Optimize existing workflows to keep things running as smoothly as possible and eliminating waste
• Engineer equipment and systems to operation in hazardous environments
• Analyze and provide engineering technical input to program process requirements from tech transfer teams
• Assist in the development of strategic plans for implementation of any new technologies and platforms, and identifies the balance between the immediate and long-term impact of technical direction and guides the organization to execution in this balance.
• Leads and collaborates with cross-functional teams, and coaches, mentors, and provides constructive feedback for junior staff and other process engineers.
• Takes part in representing department as a prime contact for expert technical assessments and engineering studies, and interacts with senior internal and external personnel on significant matters including those that require coordination between organizational units in larger groups.

Education and experience requirements

• Bachelor's degree required in Electrical, Biochemical, Chemical, or other Engineering disciplines.
• Twelve years’ experience in pharmaceutical or biotech manufacturing or engineering environments.
• Have a proven track record of the management of large technical projects/portfolios in a complex environment, and advanced expertise in small molecule and ADC process design, plant design and engineering of equipment and systems to operation in hazardous environments.

Application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis.

The Company

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, 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.