Vice President, Engineering

The Vice President of Engineering will be a business leader for the site engineering function. This pivotal role will be responsible for overseeing the engineering functions, including Automation, Process Engineering, Utilities, Commissioning, Qualification, and Validation (CQV), Facility Management and Security, and Capital Projects. The executive role will join site leadership in leading the business and ensuring engineering teams support the business strategy and provide state-of-the-art technical solutions, support robust manufacturing processes, drive continuous improvement initiatives, and upholds the highest standards of quality and compliance across the Company network.

The role will ensure a strong connection to FUJIFILM Diosynth Biotechnologies' strategic priorities and create close connection between the sites in the network on engineering topics to create and share best-practices.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

Join us

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.

Job Description

Based onsite in Holly Springs, NC - the ideal candidate will bring extensive expertise in the pharmaceutical industry and a proven track record of driving engineering excellence and successfully managing diverse teams. 

Main responsibilities

Strategic Leadership:

• Bringing the Engineering perspective to site and business leadership.

• Develop and implement the engineering strategy in alignment with the company’s mission, vision, and business objectives, and support engineering teams in developing strategies and plans supporting this, e.g. site Master plan, Facility Investment plans etc.

• Lead and mentor a high-performing engineering team, fostering a culture of innovation, teamwork, and continuous improvement within the engineering functions.

Operational Excellence:

• Oversee engineering activities related to process development, scale-up, technology transfer, equipment design and optimization, and facility expansion, including overseeing activities to:

o The design, implementation, and optimization of automated systems to enhance manufacturing efficiency and product quality, for new and existing equipment.

o Ensure the robust and reliable operation of utilities, including HVAC, water systems, and compressed gases, to support manufacturing processes.

o Direct CQV activities to ensure compliance with regulatory standards and maintain the highest levels of product quality and safety.

o Implement and maintain robust EHS programs in partnership with EHS Site Lead to ensure the highest standards of workplace safety and environmental compliance.

o Develop maintenance and security of the facility, ensuring a safe and efficient environment for all operations.

o Manage and execute capital projects to support infrastructure development and strategic growth initiatives.

o Develop and share best practices for DS and DP manufacturing of biopharmaceuticals, and how to work with cGMP guidelines.

o Ensure engineering projects meet cost, quality, and timeline targets while complying with regulatory requirements and industry standards (e.g., cGMP, FDA, EMA).

Collaboration and Partnership:

• Ensure the Engineering function works closely with cross-functional teams, including R&D, Quality, Manufacturing, Supply Chain, and Regulatory Affairs, to support product development, commercialization and technology transfers.

• Creating connections with Engineering leaders across the FDB network internally as well as externally to develop and share best practices.

• Act as a representative for Engineering practices with internal and external partners, clients, and regulatory bodies such as FDA and EMA.

Innovation and Continuous Improvement:

• Drive technological innovation and continuous improvement initiatives to enhance operational efficiency, product quality, and safety.

• Evaluate industry trends, technological advancements, and regulatory changes, and implement new technologies and methodologies to maintain a competitive edge in the market.

Compliance and Quality:

• Ensure all engineering activities, performed by FDB or potential duty holders, are executed following regulatory and safety standards, company policies, and quality systems.

• Proactively identify and mitigate risks and ensure robust validation and compliance processes are in place.

Budget and Resource Management:

• Develop and manage the engineering budget, ensuring optimal allocation of resources, cost control, and financial performance.

• Manage Capital Projects to ensure effective investment and infrastructure development in line with strategic goals.

• Oversee the planning, recruitment, and development of engineering talent to support current and future business needs.

Education and experience requirements

• Bachelor's degree in Engineering, preferably in Biochemical, Chemical, Mechanical, or other Engineering discipline; advanced degree (MBA, Master’s or Ph.D) preferred.

• 15+ years of experience in the pharmaceutical or biotechnology industry engineering environments, with at least 10 years in a leadership role.

• Comprehensive knowledge of automation systems, process engineering, utility management, and CQV practices.

• Proven ability to lead and develop high-performing engineering teams.

• Strong project management skills, with the ability to handle multiple projects simultaneously.

• Excellent communication and interpersonal skills, with a collaborative approach to problem-solving.

• In-depth understanding of regulatory requirements, including GMP, FDA, and EMA guidelines.

• Strategic thinker with a track record of driving innovation and process improvements.

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.