Senior Laboratory Engineering Support Specialist

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 maintenance, 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
• Preferred Skills & Abilities:
• Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC).
• Computer knowledge of 21 CFR Part
• Change control and
• Excellent written and oral communication
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point)
• Windows desktop and server operating system installation, configuration, and maintenance.
• Knowledge and understanding of Active Directory Services (Group Policies, DHCP, DNS, Printing, etc).
• Working knowledge of virtual technology for serving servers, workstations, and applications.
• Desire to work in fast-paced, state of the art, alternately research and customized manufacturing
• PC imaging design and
• Software installation and
• 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, stretching, and walking.
• 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
• Working on
• Be exposed to noisy
• Attendance is mandatory.

Qualifications:

• A Bachelor’s Degree in Science with five (5) years technical discipline and work experience; OR
• An Associates Degree and ten (10) years relevant work experience associated with IT, pharmaceutical, and analytical laboratory equipment experience; OR High School diploma or GED and fifteen (15) years’ relevant work experience associated with IT, pharmaceutical, and analytical laboratory equipment experience.

Preferred Qualifications:

• cGMP and cGLP
• A

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.

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