Overview

Lab Engineer II is a mid-level position in the Laboratory Engineering department of FDBU. 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 Laboratory Engineer II is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in Manufacturing, Quality Control, Analytical and Process Development. Additional responsibilities include supporting the design, procurement, installation, and start-up of new analytical equipment in accordance with FDBU 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) Systems, High Performance Liquid Chromatography (HPLC) Systems, Low Pressure Liquid Chromatography (LPLC) Systems, UV-VIS Spectrophotometers, Micro Plate Readers, Densitometers, Cell Viability Analyzers, Mass Spectrometers and various analytical data collection systems, i.e., Empower, SoftmaxPRO, and Unicorn. The Laboratory Engineer II will maintain working knowledge for all such systems allowing for effective technical support. Additionally, a sound working knowledge of Microsoft Windows operating systems, and a basic understanding of PC troubleshooting, and computer networking is a plus.

External US

Essential Functions:

• Support equipment qualification validation protocol 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

• Troubleshoot technological issues and solve problems quickly to ensure business operations run smoothly.

• Review technical equipment operating manuals for recommending routine maintenance, calibration, spare parts, and other systems as needed.

• 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 less experienced 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 equipment failure 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 tasks 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.

• Actively manage contractor activities to ensure work quality and safe practices to facilitation of contractor training

• Other duties as assigned.

Minimum Qualifications:

• Bachelor’s Degree in Science or Technical discipline with a minimum of three (3) years’ relevant technical experience; OR

• Associates Degree and six (6) years’ relevant technical experience; OR

• High School Diploma or GED and nine (9) years’ relevant experience.

• Must include a minimum of three (3) years in the bio-pharmaceutical industry in a role requiring hands on experience with analytical/process equipment covering Quality Control, Process Development or Manufacturing organizations.

Preferred Qualifications and Skills:

• Proficient with Empower SystemsQT Automation Qualification Tool for Waters and Agilent Systems

• Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC).

• Good understanding of cGMP industry standards for analytical test equipment, systems quality test requirements, and 21 CFR Part 11.

• Understands change control and CAPA.

• Effective organizational, verbal, and written communication skills with the ability to effectively communicate within cross-functional teams and to management.

• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).

• Desire to work in fast-paced, state of the art, research and customized manufacturing facility.

• Proficient computer skills with experience using Windows based operating systems with an understanding of installing, configuring, testing, and maintaining operating systems, application software and system management tools.

• Strong technical aptitude for problem solving and data driven decision making.

• Basic understanding of site initiatives and the impact on regulatory guidelines.

• Experience with analytical methods supporting biopharmaceutical processing.

• Excellent interpersonal skills and be able to work effectively and efficiently in a team-based environment.

• Maintains effective relationships across functional units gaining their trust and respect.

• Openly shares knowledge/information needed to accomplish a task or solve a problem.

• Exhibits professionalism and sets an example for others to follow.

• Self-starter and detail oriented.

• Ability to manage commitments while displaying an eagerness to learn and continuously improve.

• Effective presentation skills with the ability to clearly articulate sound reasoning and data for recommended courses of action.

• Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-technical personnel

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.

• On site work is mandatory.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Job Locations US-NC-Research Triangle Park

Posted Date 3 weeks ago (9/17/2024 6:52 PM)

Requisition ID 2024-27919

Category Engineering

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies