Instrumentation Specialist

4 weeks ago

Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time
  • Execute the qualification, routine operation, maintenance, continuous improvement and decommissioning of QC analytical instrumentation.
  • Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.
  • Author and review SOPs, technical reports, user requirements and functional specifications, and KNEAT protocols and reports.
  • Support data integrity initiatives related to analytical instruments.
  • Recommend appropriate user roles and privileges for data integrity (where applicable), write instrument operation instructions and preventative maintenance plans.
  • Work with vendors performing maintenance activities on QC analytical instruments.
  • Complete periodic reviews of QC instruments and associated instrument control software.
  • Identify and follow-up on excursions and deviations and initiate corrective and preventative actions (CAPAs) related to analytical instruments.
  • Support stakeholders, including end users, with issues and guidance related to QC analytical instruments.
  • Work cross functionally with all end users, Validation Team, Labware Specialists, and Quality Assurance.
  • Performs other duties, as assigned


Minimum Requirements:

  • Bachelor’s degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 3+ years of relevant experience OR
  • Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 1 year of relevant experience
  • 1- 3 years relevant experience, experience in a GMP environment


Preferred Requirements:

  • Experience with KNEAT software
  • Experience qualifying analytical instruments
  • Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.

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