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Sr. Validation Engineer

Hillerød, Denmark

The Company

Fujifilm Diosynth Biotechnologies is a company on the journey to become the leading and most trusted global Contract Development and Manufacturing Organization partner in the biopharmaceutical industry. A great opportunity to accelerate your career and join a great company.

Information Technology is a part of Digital Technologies which is a fast growing department responsible for driving the digital transformation for the site. You will be surrounded by highly dedicated and skilled colleagues who all works on the mission of ensuring stable, efficient and compliant IT solutions. Simplicity and agility is important in everything we do.

The Job

We are looking for an energetic Sr. Validation Engineer to join our Digital Technology department, where you will be joining our transformation journey to deliver new and exciting technologies to a fast growing company.  You will be help shape the overall strategy for Computerized System Validation (CSV) within Digital Technologies, including setting the CSV specific direction for small and large projects, both across traditional IT and Automation Engineering. 

In your role as a Sr. Validation Engineer you will be part of a newly established CSV team where we aim to act as consultants and ambassadors for good IT practices to the larger Digital Technologies organization, while ensuring consistent planning and delivery on our busy project portfolio. As the Sr. Validation Engineer you will provide guidance and mentorship to your CSV colleagues, and ensure a close and collaborative dialogue with QA/IT Quality to ensure common understanding of our ITQMS and delivery methodologies.  

You are quality minded with a great understanding of regulatory and compliance requirements around IT/Computer systems, coupled with a solid understanding of IT delivery and validation processes.  Ideally you have experience validating cloud based systems/services, and in presenting to regulatory bodies/agencies during inspections.

Tasks:

  • Support in setting the overall CSV strategy and set the direction on CSV for specific projects and implementations
  • Coaching and mentorship of CSV colleagues
  • Execute and coordinate validation tasks and support projects in Digital Technologies and support areas, to keep the equipment and systems in compliance
  • Optimize v-model deliveries/gates to various project delivery methodologies (such as Agile)
  • Identify and implement improvements within the Digital Technologies organization 
  • Support the CSV team to prepare and execute projects in compliance
  • Contribute with knowledge and experience in validation issues
  • Support Digital Technologies organization with compliance related matters
  • First line of support for customer and regulatory agency audits/inspections.

Requirements:

  • Bachelors Degree in engineering, computer science or similar.
  • 5-10 years industry relevant experience in related areas preferably within the pharmaceutical industry.
  • Knowledge of manufacturing and cGMP 
  • Familiarity with ITIL concepts and IT Project delivery 
  • Solid knowledge of GAMP5
  • In depth knowledge of regulatory requirements and expectations, such as 21 CFR Part 11, EudraLex Annex 11, PIC/S, 
  • Structured with strong analytical skills
  • Strong networking and interpersonal skills 
  • High sense of responsibility
  • Fluent in English; verbal and written (corporate language)

Your Application

Please upload your CV and cover letter as soon as possible

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FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with global locations including one in Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies. Among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.

Our manufacturing site in Hillerød, Denmark, is a large-scale manufacturing facility with a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use.

FUJIFILM Corporation has announced the investment of approx. 6 billion DKK. into the site to double the manufacturing capacity, to add a fill finish capacity and to enhance the assembly, label and pack services on site. The current organization is approximately 800 employees and will grow significantly as a result of the investments. The company takes pride in enriching their communities, caring for their environment, and cultivating a world of opportunity for future generations.

At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics Contract Development and Manufacturing Organization. We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible for employees to develop personally and learn. They can pursue their fullest potential as individual contributors and team members. Customer trust, digitalization, best place to work and expansion of capacity and end-to-end capabilities are cornerstones of the Fujifilm Diosynth Biotechnologies strategy in Hillerød, DK.