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.
- 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 FDBU 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
- Develop, mentor, and train 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
- 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 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, 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 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.
- 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 organizations.
- 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.
- 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 email FDBTHR@fujifilm.com or call 979-431-3528.