Laboratory Engineering Technical Support I

Summary : Laboratory Engineering Technical Support I is an entry-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 direct supervision, the Laboratory Engineer I is responsible for assisting with 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. Basic pc troubleshooting and maintenance is a plus. This position may require support outside of normal business hours.

In this position, you will gain 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, SoftMax PRO, and Unicorn. The Laboratory Engineer I will maintain working knowledge for all such systems allowing for effective technical support. Additionally, a basic understanding of networking and Microsoft Active Directory is a plus.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and 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 people’s 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 FUJIFILM Diosynth Biotechnologies 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.

Job Description

Essential Functions:

• Support validation protocols execution.
• Provide hands-on and effective diagnostics/troubleshooting functions.
• Assist with supporting the design and implementation of sound engineering solutions for mitigating existing operational issues, driving continuous improvement, and introducing new technology in accordance with FDBT standards and cGMP regulatory requirements.
• Help provide laboratory engineering support for capital projects concurrently with a dynamic workload based upon site priorities.
• Review technical equipment operating manuals for recommending routine maintenance, calibration, spare parts, etc.
• Assist with 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.
• Help review and revise laboratory engineering 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.
• Interface with IT to ensure GMP and GLP compliant integrations.
• Assist and participate in system, specification development, and design.
• Support data integrity initiatives.
• 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 assigned.
  
  

Preferred Skills & Abilities:

• Familiar with GAMP and other approaches to System Development Life Cycles (SDLC).
• Knowledgeable of 21 CFR Part 11.
• Ability to initiate change controls and CAPAs effectively.
• Excellent written and oral communication skills.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
• Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
• Familiar with PC imaging design and testing.
• Familiar with software installation and testing.
• Ability to collaborate and effectively partner with team members within and outside of the department in a professional manner.
  
  

Qualifications:

• High School Diploma or GED
• Minimum of one (1) year of previous experience in technical support role.
  
  

Preferred Qualifications:

• Bachelor's degree in computer science or technical discipline.
• Previous cGMP and cGLP experience.
• A Certification or equivalent training.
  
  

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
• Working on ladders.
• Ability to wear PPE if required.
• Be exposed to noisy environments.
• Attendance is mandatory.
  
  

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).