- Provide tech transfer project to enable completion of process validation and health authorities submission technical packages.
- 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.
- 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.
- 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.
Harvest TechnicalHarvest 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!