Manager, Laboratory Engineering

Location
College Station, TX
Posted
Dec 04, 2021
Ref
2021-18089
Hotbed
Lone Star Bio
Required Education
Associate Degree
Position Type
Full time

  Our engineering team in College Station, Texas is expanding and we are looking for a Manager, Laboratory Engineering to be responsible for day-to-day technical support, maintain, preventive maintenance program and enhance laboratory systems and instruments. In addition, this position is a major contributor for the implementation of new technology, instruments and systems within manufacturing, quality control, analytical and process development organizations.

Additional responsibilities include supporting the design, procurement, installation and start-up of new analytical equipment in accordance with FDBT standards and cGMP/cGLP regulatory requirements. This position may require support outside of normal business hours.

External US

Essential Functions:

  • Lead the establishment of the department and the team, including hiring of staff, ensure effective operation, organization and delivery of the department functions.
  • Develop and grow the technical expertise of the team.
  • 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 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 and plan 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 instruments 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.
  • 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.

 

Qualifications:

  • B.S. Degree in Science/Technical discipline with 7+ years' relevant technical experience or A.S Degree in Science/Technical disciple with 15+ years' equivalent work experience. Must include 5+ years' in the bio-pharmaceutical industry in a role requiring hands on experience with analytical/process equipment.
  • 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.

 

Preferred Qualifications:

  • 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.

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