Lead for Quality Deviations (Resilience Engineer)

Are you driven to understand and learn; and are eager to lead the quality deviation process at FDBD. To continuously seek and explore the cause of deviations and facilitate the identification of meaningful CAPAs? Do you have a flair engaging both our internal stakeholders and our customers?

Then look no further, come and join this fantastic team on our exciting journey.

The role

The Resilience Engineer is responsible for maximizing organizational learning through the application of systematic and analytical cause analysis techniques inclusive of Human and Organizational Performance principles to each quality investigation.

Furthermore the Resilience Engineer applies appropriate methodology for each given situation, facilitates the cross function team appoint to investigate the atypical incident and collects and synthesizes data in order to identify causes that if addressed would prevent recurrence. The investigations range from remedial action requests to high risk deviations.

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

The 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.

Your primary tasks will be to:

• Drive investigations for quality deviations forward in an active and leading role.
  
  
• Organize, lead, and facilitate cross-functional investigation teams.
  
  
• Conduct quality investigations with focus on performance improvement and risk reduction, in alignment with the Pharmaceutical Quality System requirements and governing regulations.
  
  
• Documents investigation reports and findings in designated quality systems and ensures required management and quality approvals on final investigations while satisfying established due dates.
  
  
• Facilitates 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, Organizational Psychology, Forensics or a related scientific discipline. Knowledge in drug substance and/or Drug product manufacturing is an advantage.
  
  
• +5 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 you are

• Building trust, respect, and collaboration across the organization.
  
  
• Actively engaged, action-oriented, resilient, passionately neutral in leading investigations.
  
  
• Motivated by having a high impact position.
  
  
• Utilizing your high level of energy and can-do attitude to proactively handle the various tasks at hand in an entrepreneurial environment

Contact

If you need more information about the role, please contact Hans Christian Troelsen at +45 77416391

Your Application

Please upload your CV and cover letter as soon as possible as we screen applications on a continuous basis.

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 site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.

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.

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.

Kilde: Jobnet.dk