5305 Tech Transfer Engineer I
Provide tech transfer project support 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 requests, 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.
Develop data mining scripts using MS tools to execute translation of 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 cGMP’s 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.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.