Laboratory Engineering Technical Support I

Overview

Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)

The work we do at FDB 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 FDB call Genki

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 minimal supervision, the Laboratory Engineer I 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. Basic pc troubleshooting and maintenance is a plus. 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 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.

External US

Essential Functions:

Support validation protocols execution.

Provide hands-on and effective diagnostics/troubleshooting functions

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 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 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 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 supervision.

Interface with IT to ensure GMP and GLP compliant integrations.

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, regulations, and industry codes.

Perform other duties as assigned.

Preferred 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.

PC imaging design and testing

Software installation and testing

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.

Be exposed to noisy environments.

Attendance is mandatory.

Qualifications:

Bachelor’s Degree in Science/Technical discipline; OR

Associates degree and three (3) years relevant work experience associated with analytical laboratory equipment; OR

High School diploma or GED and five (5) years’ relevant work experience associated with analytical laboratory equipment.

Preferred Qualifications:

cGMP and cGLP experience.

A+ certification.

Salary: Starting salary will be commensurate with education and 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 FDBTHR@fujifilm.com or call 979-431-3500.