FUJIFILM -Responsible Engineers, Upstream Process Engineering

FUJIFILM Diosynth Biotechnologies located in Hillerød, Denmark, is expanding. Therefore we have two new positions as equipment responsible engineers. In this role, you will provide crucial support for clinical and commercial manufacturing of drug substance, improvements, quality/operational robustness/cost savings initiatives while ensuring compliance with cGMP, quality and safety standards for FDA regulated products.

You will be part of the Upstream Process Engineering team which is situated in the Engineering Support department. The overall responsibility of Upstream Process Engineering is to secure that the upstream manufacturing equipment is available for manufacturing when needed. The team consists of 12 responsible engineers.

The position interacts closely with the Drug Substance manufacturing team as well as several engineering disciplines such as Quality, Automation, Validation, Process Science, Plant Engineering, Maintenance, and Project Engineering.

Responsibilities

·       Support the production and secure reliable and robust operations. Onsite support needs may occur in the evening and/or weekends and participation in the engineering on-call program is required on rotational basis.

·       On the floor presence and support after any critical process equipment changes.

·       Support tech transfer activities of new processes from customers to the production site in Hillerød

·       Focus on operational robustness and cost efficiency in everyday work and processes. Drive, support, and perform assessment based on impact and effort for prioritization.

·       Drives equipment changes, specify and install new equipment, provides engineering technical support and troubleshooting for all cell culture equipment as required.

·       Review validation protocols and supports validation testing.

·       Provides project engineering support as required for new processing equipment installations and modifications to existing equipment.

·       Participate in cross-functional teams to implement changes and / or improve existing processes.

·       Provide training as needed to ensure production team understands equipment functionalities.

·       Communicate progress, status, and issues to stakeholders and upper management.

Requirements:

·       Minimum a Bachelor’s Degree within engineering or similar discipline.

·       5+ years of experience in the areas of GMP manufacturing, engineering or facilities in a pharmaceutical environment.

·       Enjoy working as part of a team and also being comfortable working independently.

·       Experience working with Cell Culture equipment in a commercial environment is a big advantage.

·       Fluent in English both verbal and written. 

Please upload your CV and cover letter as soon as possible as we will screen candidates on a continuous basis. For more information about the job please contact Esben Eggertsen, Manager Process Engineering at +45 41949739

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.

Application via website: https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Responsible-Engineers--Upstream-Process-Engineering_JR1396