Laboratory Engineering Technical Support I
Laboratory Engineering Technical Support I
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Job Description
Position Overview
Summary: Laboratory Engineering Technical Support I is an entrylevel position in the Laboratory Engineering department of FDBT. The primary purpose of this position is to provide daytoday 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 startup 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 UltravioletVisible 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 importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven 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 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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 .
- Provide handson 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 fastpaced 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:
Bachelors 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 handeye 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 email or call.
EEO Information
Fujifilm is committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.
Employment Type
Unclear
