Senior Engineer, Lab Engineering at Fujifilm Manufacturing USA, Inc in Triangle, VA
Overview Senior Laboratory Engineer 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. External US Senior Laboratory Engineer 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 Senior Laboratory Engineer is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment. 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 working knowledge of typical biopharmaceutical analytical equipment 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. This position directly reports to the Associate Director of Automation within Engineering department but may also have a functional reporting relationship to a senior colleague on a project to project basis. MAJOR ACTIVITIES AND
Responsibilities:
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 Other duties as assigned BACKGROUND REQUIREMENTS:
Education/
Experience:
S. Degree in Science/Technical discipline with 7
years' relevant technical experience or 12
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. 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.
Qualifications:
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 Good understanding of cGMP industry standards for analytical test equipment, systems quality test requirements, and 21 CFR Part 11 Basic understanding of site initiatives and the impact on regulatory guidelines Experience with analytical methods supporting biopharmaceutical processing Effective organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management 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 FDBU works with technical data, technology and materials that ar
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
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 Other duties as assigned BACKGROUND REQUIREMENTS:
Education/
Experience:
S. Degree in Science/Technical discipline with 7
years' relevant technical experience or 12
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. 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.
Qualifications:
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 Good understanding of cGMP industry standards for analytical test equipment, systems quality test requirements, and 21 CFR Part 11 Basic understanding of site initiatives and the impact on regulatory guidelines Experience with analytical methods supporting biopharmaceutical processing Effective organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management 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 FDBU works with technical data, technology and materials that ar
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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