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Senior Laboratory Engineering Support Specialist

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Job LocationsUS-TX-College Station

Posted Date

7 days ago

(12/26/2024 12:31 PM)

Requisition ID : 2024-32763

Category : Engineering

Company (Portal Searching) : FUJIFILM Diosynth Biotechnologies

Overview

The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

External US

Summary:Senior Laboratory Engineering Technical Support Specialist is a senior-level position in the Laboratory Engineering department of FDBT. The primary purpose of this position is to provide day-to-day technical support for the analytical pcs and equipment within Manufacturing, Quality Control, Analytical and Process Development organizations. In addition, this position is a major contributor to supporting new technology and equipment life cycle monitoring.

Under minimal supervision, the Senior Laboratory Engineering Tachnical Support Specialist is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, analytical, and process development. Additional responsibilities include supporting the design, procurement, installation, and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements. PC troubleshooting and maintenance along with knowledge of Microsoft Windows Desktop and Server operating systems are required. This position will require support outside of normal business hours.

This position requires a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftmaxPRO, and Unicorn. The Senior Laboratory Engineering Technical Support Specialist will maintain working knowledge for all such systems allowing for effective technical support. Additionally, understanding of basic networking and a general understanding of Microsoft Active Directory is required an understanding of NTFS file and share security permissions.

Essential Functions:

Support validation protocols

Provide hands-on and effective diagnostics/troubleshooting

Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBT standards and cGMP regulatory requirements.

Provide laboratory engineering support for capital projects concurrently with a dynamic workload based upon site priorities.

Review technical equipment operating manuals for recommending routine maintena ce, calibration, spare parts, configuration, administration, etc.

Act as a subject matter expert for the development of engineering and validation documents, i.e., User Requirement Specification, Functional Specification, Design Specifications, and Guidelines for new and existing analytical/process equipment systems.

Assist with training coworkers as well as peers on analytical equipment functionality, troubleshooting, and diagnostic techniques to enhance the overall capability of the organization.

Develop and revise laboratory engineering

Capable of understanding and following SOPs.

Support investigations to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.

Interface and build collaborative partnerships with key site functions including Manufacturing, Analytical and Process Development, Technical Operations, Engineering, and Quality to deliver site goals and objectives.

Lead simple with minimal guidance and

Interface with IT to ensure GMP and GLP compliant

Prepare, assist, and participate in system specification development and

Support data integrity initiatives and department, client, and governmental audits.

Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations, and industry codes.

Perform other duties as

Prefer