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8860 Tech Transfer Engineer I

Harvest Technical Vacaville ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Duties: 

  • Provide tech transfer project to enable completion of process validation and health authorities submission technical packages.

Responsibility includes:

  • Develop and execute logistics for analytical data supportive of technical and process validation studies. This includes: coordination with Manufacturing, Process Engineering, Quality Control, and Process Technical Development on non-routine sampling request, sample aliquoting, sample shipment, testing lab coordination, and test results compilation.
  • Collaborate with Process Engineering and Quality Assurance to translate qualification runs batch genealogy into run context.
  • Develop and execute translation of electronic batch records into process summary.
  • Perform data verification of translated information from electronic batch records into process summary.
  • Prepare technical package for data summary and supportive information to support conclusion of technical and process validation studies.
  • Provide support on technical documentation logistics.
  • Creates and maintains dashboard communication and visual management strategies to track activities assigned for ease of reporting to project lead(s).
  • Occasionally, the position may involve some work during non-business hours.

Skills:    

  • Solid understanding of basic engineering techniques and principles, and the ability to apply that knowledge.
  • Must be able to clearly communicate information to a varied audience and good technical writing skills
  • Effective communication and interpersonal skills with technical, operations, quality  personnel as well as project/process engineering  personnel
  • Thorough understanding and application of cGMPs particularly as they relate to the Good Documentation Practices (GDP)
  • Outstanding organization and attention to detail
  • Ability to adapt to changing priorities
  • Ability to work independently, seek stakeholders input, and drive assignments to completion
  • Knowledge or previous experience on monoclonal antibody production processes and statistics (including the use of statistical software such as JMP) is highly desirable.

 

Education: 

  • Minimum of 2 years of related experience, preferably in the B.S./M.S./Ph.D. in Chemical/Biochemical Engineering, or other Engineering/Life Sciences majors.

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Company Description
Harvest Technical Services, Inc. (Harvest) provides engineering, design, research, QA/QC, and construction staffing solutions for the petrochemical, biopharmaceutical, water/wastewater, power, and related industries throughout the United States. Please visit www.harvtech.com for a complete list of available employment opportunities!

Harvest Technical

Harvest Technical Services, Inc. (Harvest) provides engineering, design, research, QA/QC, and construction staffing solutions for the petrochemical, biopharmaceutical, water/wastewater, power, and related industries throughout the United States. Please visit www.harvtech.com for a complete list of available employment opportunities!

Address

Vacaville, CA
USA

Website