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Resilience Engineer for Quality Deviations

FUJIFILM Diosynth Biotechnologies


Hillerød, Denmark
Do you have a small detective hidden and is eager to lead the Quality deviation process, to continuously seek and explore the cause of deviations and facilitate the identification of meaningful CAPAs?
Then don’t hesitate anymore, come and join our fantastic team on our exciting journey.

About the position
The Resilience Engineer is responsible for maximizing organizational learning and improvement from Quality deviations and applies systematic and analytical cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation assigned.

Furthermore the Resilience Engineer applies appropriate methodology for each given situation, facilitates investigation team meetings, conducts interviews, and collects and synthesizes data in order to identify causes that if addressed would prevent recurrence. The assigned investigations include cross-site alert actions, remedial action requests and higher risk deviations.

About the department
The main function of the team is to drive the Quality deviation process to continuously seek the cause of these deviations, explore the extent of the cause or condition and facilitate the identification of meaningful CAPAs to prevent the recurrent of similar incidents.

Tasks

  • Leads investigations for Quality deviations and incidents.
  • Conducts Quality investigations with focus on performance improvement and risk reduction, in alignment with Quality Management 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.
  • Presents investigations during internal and external audits and inspections.

About your qualifications and competences

  • Minimum educational level necessary to perform the job (High School diploma, Associate’s Degree, Bachelor’s Degree, Masters, PhD
  • S. degree in Engineering, Organizational Psychology, Forensics or a related scientific discipline
  • A minimum of 5 years of experience with B.S.; 8 years of experience with A.S.; with that experience in a lab and operations environment (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 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.
  • Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
  • Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.

Contact
If you need more information about the role, please contact Hans Christian Troelsen at 77 41 63 91

Your Application
Please upload your CV and cover letter latest by September 27, 2020. We process applications as they arrive so please send your application as soon as possible.

APPLY

We offer

  • A strong collaborative culture and a one team spirit
  • We represent many different backgrounds and look forward to welcoming more than 300 new colleagues to further strengthen our diversity and capabilities as part of a fast growing international company
  • Our compensation and benefit package is competitive and we strive to become an employer of choice

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



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Ansøgningsfrist d. 27.09.2020
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FUJIFILM Diosynth Biotechnologies - hurtigt overblik


Placering
Biogen Alle 1
3400 Hillerød
Logo: FUJIFILM Diosynth Biotechnologies
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