Laboratory Engineer II

2 weeks ago


Durham, North Carolina, United States FUJIFILM Holdings America Corporation Full time
Job Title: Laboratory Engineer II

Overview

The work we do at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. has never been more important. We are seeking a talented Laboratory Engineer II to join our team. As a Laboratory Engineer II, you will play a critical role in supporting our laboratory operations and ensuring the quality of our products.

Key Responsibilities
  • Interface and build collaborative partnerships with key site functions, including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives.
  • Actively support QC Lab requests and engineering projects.
  • Maintain and support manufacturing QC systems.
  • Maintain 100% customer satisfaction for all technical support calls.
  • Provide hands-on diagnostic/troubleshooting support for QC process and monitoring systems.
  • Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements while following GAMP guidelines.
  • Support capital projects from conception, design, and initial specifications through completion and turnover.
  • Develop/Revise User Requirement Specifications, Functional Specifications, Design Specifications, SOPs, and Guidelines for new and existing QC systems.
  • Lead, support, and perform investigations relating to complex manufacturing and QC deviations and anomalies associated with QC systems and control system software in order to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.
Requirements
  • BSc./Chem. Eng. degree or equivalent; or 3+ to 5+ years related experience and/or training; or equivalent combination of education and experience.
  • GMP Experience: Laboratory Engineer II is a mid-level position in the Laboratory Engineering department of FDBU, requiring three years of GMP experience.
  • Basic knowledge of FDA regulation 21 CFR Part 11.
  • Knowledge of Data Integrity on FDA regulated environments.
Working Conditions

The Laboratory Engineering department provides 24-hour support for manufacturing and laboratories. This position will be required to support off-hours requests.

The Major Equipment and Systems that are supported include, but are not limited to:

  • Ultra Performance Liquid Chromatography (UPLC)
  • High Performance (Pressure) Liquid Chromatography (HPLC)
  • Liquid Chromatography/Mass Spectrometry
  • Ultraviolet-Visible Spectroscopy
  • Plate Reader
  • Densitometry
  • Cell Counting
  • Chromatography Data Systems
  • Experience using laboratory equipment such as pipettes, balances, pH meters.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.


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