Resilience Engineer

Are you driven to understand and learn? Are you eager to drive quality deviation processes and liase as an Investigator? To continuously seek and explore the cause of deviations and facilitate the identification of meaningful CAPAs? Do you have a flair for engaging both internal and external stakeholders? Are you looking for a role that will challenge you in the best way possible?

Then look no further, as we have a unique opportunity to join us here at FUJIFILM Diosynth Biotechnologies as our Resilience Engineer. Come and join this fantastic team on our exciting journey!

Welcome to the Manufacturing Support Function in DSM
The team is a Manufacturing Support function within the Drug Substance Manufacturing (DSM) Department. The main function of the team is to drive the quality deviation process to ensure we minimize recurrence of these incidents, learn, improve and ensure we continue to delight our customers and provide the patient with the highest quality product.

Who you’ll be working with
We are a dynamic, high performing team of 11 members representing 9 different nationalities. The team thrives on learning from each other, from a cultural and technical aspect.

Your New Role
As our new Resilience Engineer, you will apply appropriate methodology for each given situation, facilitate investigations with the cross functional team appointed, to address atypical incidents. Further to this, you will collect and synthesize data to identify causes that, if addressed, would prevent recurrence. These investigations will range from Remedial Action Requests (RARs) to high-risk deviations.

In this role you will be the key contact for presenting investigations to customers, the wider organization and during audits/inspections. Strong communication skills are a necessity for this role, as you will cover a broad variety of tasks related to internal stakeholders, customer interface and senior management.

You will be responsible for maximizing organizational learning through the application of systematic and analytical cause analysis techniques inclusive of Human and Organizational Performance (HOP) principles to each quality investigation.

Your primary tasks will entail but not be limited to:

• Organize, lead, and facilitate cross-functional investigation teams.
• Drive investigations for quality deviations forward in an active and leading role.
• Conduct quality investigations with focus on performance improvement and risk reduction, in alignment with the Pharmaceutical Quality System requirements and governing regulations.
• Document investigation findings in reports and designated quality systems and ensure required management and quality approvals on final investigations while satisfying established due dates.
• Facilitate internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness.
• Present ongoing investigation status to customers.
• Presents investigations during internal and external audits and inspections.

Your Talent

• B.S. / M.S. degree in Engineering, Forensics, or a related scientific discipline.
• Knowledge in drug substance and/or Drug product manufacturing is an advantage.
• 1-2 years of experience (industrial/plant experience preferred).
• Experience in performance improvement with basis in Human and Organizational Performance principles.
• Practical knowledge and application of cGMP, cGLP, EMEA and experience interfacing with customers, inspectors, investigators and/or agency personnel.
• Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
• Effective facilitation skills to internal stakeholders, customers and senior management.
• Experience in management of diverse stakeholders with strong interpersonal/influencing skills.
• Ability to balance resource demands from multiple internal stakeholders.
• Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.
• Strong verbal and written English communication skills and comfortably and clearly articulate issues across the organization and to customers.
• Experience with customer interface is an advantage.

As a person, we hope you are someone who can easily build trust with others and collaborate across the organization. You are a naturally proactive, curious, and resilient person who can maintain neutrality when leading investigations. We hope that you are motivated by being positively challenged and knowing that you can have a high impact within the organization. And lastly, we believe that someone outgoing with an action-oriented can-do attitude will thrive in the entrepreneurial environment which lies within this role.

Your application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we screen applications on a continuous basis. We will take down the advert when the position has been filled.

Working at FUJIFILM Diosynth Biotechnologies
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

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.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

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, color, 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.

Location: FDBD Hillerod