Senior Process Engineer / Technical Lead

FUJIFILM Diosynth Biotechnologies are in the process of expanding its Drug Product (DP) and Finished Goods (FG) Manufacturing capabilities and we are therefore looking for a dedicated, result-oriented Senior Process Engineer for our Engineering Sciences team in Hillerød.

The team provides engineering technical leadership, and primarily designs, and specifies new equipment and provides engineering technical support for all Drug Substance (DS), Drug Product (DP) and Finished Goods (FG) processing equipment and utilities on the site. They are subject matter experts in technical investigations and in the technology transfer of new products/processes. They lead continuous improvement, equipment and facility performance optimization efforts and provides technical engineering expertise for new processing equipment installations and modifications to existing equipment.

Primary responsibilities

  • Manage assessments and feasibility studies for prospective new and expanded capabilities for equipment, manufacturing and other requirements. These cover bulk Drug Substance, Drug Product and Finished Product manufacturing operations, and support facilities.Technical leadership in the assessment and process design / fits for new equipment, facility and operational capabilities.
  • Drives engineering studies to confirm process fit to plant for new processes and changes to existing processes
  • Provides expertise and advice to guide the activities of a major project or activity.
  • Actively identify gabs and suggest/drive implementation of improvements within the DS, DP and FG manufacturing areas.
  • Performs process simulation to optimize throughput and identify potential bottlenecks
  • Interaction with senior internal and external personnel on significant matters often requiring coordination between Organizational Units.
  • Provide regular updates to Sr. Leadership on strategic initiatives, key technical efforts, facility fits and investments
  • Experts in the process equipment and technologies within Engineering

Qualifications / Skills

  • Solid experience with Drug Product (DP) and/or Finish Goods (FG) process equipment and unit operations.
  • Knowledge of early phase equipment design and facility layouts
  • Experience with isolators and robot technology would be beneficial but not required
  • Has achieved an advanced level of expertise and is capable of working on problem solving and a variety of different projects or assignments.
  • Collaborative attitude with the willingness to work with global peers toward company and department goals. Focused dedication with the willingness to do what it takes to get the job done.
  • Ability to lead large group meetings, including cross functional groups and external partners and organizations
  • Knowledge of GMP and EMEA/FDA regulations (or experience working in a similar highly regulated environment)
  • Excellent oral and written communications skills in English

Education

  • Master‘s or Bachelor’s degree in a scientific or engineering subject with a minimum of 10 years related industry experience.
  • Please upload your CV and cover letter as soon as possible and latest by February 16th.

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