Facility Expert with GMP Knowledge

3 weeks ago


Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full time

We are seeking an experienced Facility Subject Matter Expert to join our team at Fujifilm Diosynth Biotechnologies. As a key member of our Facility Group, you will provide expert guidance on GMP-related matters and ensure the smooth operation of our facility.

Job Description

The ideal candidate will have extensive knowledge of cGMP regulations and guidelines, as well as experience working in a fast-paced manufacturing environment. You will be responsible for driving facility-related changes, updating procedures, and conducting facility walks to ensure compliance with regulatory requirements.

In addition, you will participate in inspections and audits, collaborate with internal stakeholders and external partners, and contribute to process improvements within the Facility department.

Responsibilities
  • Drive Facility related changes
  • Update/creation of Facility procedures
  • Act as a Facility SME in our event reporting system and drive deviations
  • Conduct Facility walks on site
  • Participate in Facility projects and improvements
  • Participate in inspections and audits
Requirements
  • Experience within electronic document systems
  • Experience in a cGMP facility
  • Strong communication skills and fluency in English
  • Great leadership skill as managing of external contractors is essential
  • Flair and passion for process optimization
  • You are self-starting and have a flexible, dynamic approach to work
  • Lastly, you see yourself as a high performing team player who is ambitious on behalf of the team

In this role, you will work closely with the Facility Management team to ensure seamless integration with the rest of the organization. We offer a competitive salary package, including a base salary of $120,000 per year, and opportunities for professional growth and development.

Fujifilm Diosynth Biotechnologies is committed to creating a collaborative and innovative work environment where diverse perspectives and ideas come together to achieve excellence. We strive to foster a culture that values teamwork, open communication, and continuous learning.



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