Senior Laboratory Engineering Support Specialist

FujifilmCollege Station, TX
377d

About The Position

The Senior Laboratory Engineering Technical Support Specialist at FDBT is a senior-level role responsible for providing technical support for analytical equipment across various departments including Manufacturing, Quality Control, and Process Development. This position involves operational maintenance, calibration, troubleshooting, and supporting the lifecycle of new technology and equipment. The role requires a strong understanding of pharmaceutical analytical equipment and the ability to work collaboratively with multiple teams to ensure compliance with regulatory standards.

Requirements

  • Bachelor's Degree in Science with five years of relevant technical experience, or an Associate's Degree with ten years of experience, or a High School diploma with fifteen years of relevant experience.
  • Sound working knowledge of pharmaceutical analytical/processing equipment.
  • Experience with Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), and Mass Spectrometry.
  • Knowledge of Microsoft Windows Desktop and Server operating systems.
  • Understanding of basic networking and Microsoft Active Directory.

Nice To Haves

  • Familiarity with GAMP and System Development Life Cycles (SDLC).
  • Knowledge of 21 CFR Part Change control.
  • Excellent written and oral communication skills.
  • Experience with Microsoft Office products (Outlook, Word, Excel, PowerPoint).
  • Working knowledge of virtual technology for serving servers and applications.

Responsibilities

  • Provide day-to-day technical support for analytical equipment in Manufacturing, Quality Control, and Process Development.
  • Support the design, procurement, installation, and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements.
  • Perform operational maintenance, calibration, and troubleshooting of analytical equipment.
  • Support validation protocols and provide effective diagnostics/troubleshooting.
  • Act as a subject matter expert for engineering and validation documents.
  • Assist in training coworkers on analytical equipment functionality and troubleshooting techniques.
  • Interface with key site functions to deliver site goals and objectives.
  • Support investigations to identify root causes and implement corrective actions.

Benefits

  • Health insurance coverage
  • 401k retirement savings plan
  • Paid holidays
  • Professional development opportunities
  • Flexible scheduling options
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