Senior Laboratory Engineer
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: November 20, 2022
Senior Laboratory Engineer is a mid-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 equipment within Manufacturing, Quality Control,
Analytical and Process Development organizations. In addition, this
position is a major contributor to implementation of new technology
and equipment life cycle monitoring. Under minimal supervision, the
Senior Laboratory Engineer 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. This position may 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 Engineer will maintain working
knowledge for all such systems allowing for effective technical
support. External US Essential Functions
- Support validation protocols execution.
- 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
- Review technical equipment operating manuals for recommending
routine maintenance, calibration, spare parts, 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
- Develop, mentor, and train coworkers as well as peers on
analytical equipment functionality, troubleshooting, and diagnostic
techniques to enhance the overall capability of the
- Develop and revise laboratory engineering SOPs
- Support investigations to properly identify root cause and
implement appropriate corrective and preventative actions to
- 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
- Actively manage contractor activities to ensure work quality
and safe practices to facilitation of contractor training
- Lead simple or complex projects with minimal guidance and
- Interface with IT to ensure GMP and GLP compliant
- Prepare, 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,
regulation and industry codes.
- Perform other duties as assigned. Required Skills & Abilities
- Familiarity with GAMP and other approaches to System
Development Life Cycles (SDLC).
- Computer knowledge of 21 CFR Part 11.
- Change control and CAPA.
- 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.Working Conditions &
Physical RequirementsThe 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
- 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.
- Be exposed to noisy environments.
- Attendance is mandatory. Qualifications
- B.S. Degree in Science/Technical discipline with 7+ years'
relevant technical experience or 15+ years' equivalent work
experience associated with analytical laboratory equipment. Must
include 5+ years' in the bio-pharmaceutical industry in a role
requiring hands on experience with analytical/process equipment
covering Quality Control and Process Development
- M.S. Degree in Science/Technical discipline with 5+ years'
relevant technical experience. Must include 3+ years' in the
bio-pharmaceutical industry in a role requiring hands on experience
with analytical/process equipment covering Quality Control and
Process Development organizations. Preferred Qualifications
- cGMP and cGLP experience.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 or call .
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Senior Laboratory Engineer, Engineering , College Station, Texas
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