TeVido BioDevices Process Engineer
We are seeking a highly motivated scientist or engineer to perform process validation/optimization and quality engineering. This individual should be adept at, and interested in, learning new skills as the company moves from process development into manufacturing. This is a challenging and exciting opportunity to contribute to an innovative, fast paced startup in Austin, TX whose mission is to enhance a patients’ quality of life using their own tissue.
This position will perform cell isolation from fresh human tissues, mammalian cell culture, and other lab-based work to support the commercial development of TeVido’s cell manufacturing process and develop quality engineering methodologies and documentation that meet FDA requirements for a cGMP facility. The successful candidate will be expected to operate and maintain lab equipment, perform experiments, analyze results, and maintain accurate documentation. Previous lab experience with aseptic technique or mammalian cell culture is required. Candidates must be eligible to work in the US. Relocation expenses are not covered.
- Design and conduct experiments for human cell isolation and culture process optimization and/or improvement
- Assist in designing requirements for and performing product verification and validation testing
- Conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials and develop appropriate quality tests and standards.
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Appropriately document experiment plans and results, including protocol writing and reports
- Provide process development and quality engineering support to manufacturing operations
- Use Microsoft Office (Word, Excel, PowerPoint) to document, analyze, and present results
- Maintain lab equipment and inventory, keep lab environment clean and well organized
- A Bachelor’s degree in life sciences or engineering with specialization in a biological science discipline with 1-3 years’ experience, or an Associate’s degree in biology or biotechnology with 2-5 years’ experience
- Experience with aseptic technique and basic lab equipment (microscopes, centrifuges, incubators, etc.)
- Experience with culturing and maintaining mammalian cells
- Knowledge of hazardous chemicals handling and best practices
- Advanced computer skills, including statistical/data analysis and report writing skills
- Demonstrated ability to successfully handle multiple complex tasks at the same time while meeting strict deadlines
- Excellent interpersonal skills, time management, communication, and demonstrated attention to detail
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
Desired additional qualifications:
- Experience with skin cell types or harvesting cells from tissue
- Experience conducting cell based assays such as, viability, immunostaining, flow cytometry, ELISA,or PCR
- Familiarity with quality systems and documentation,cGMP practices, and FDA requirements
- Ability to discover and interpret relevant technical literature
- Ability to apply engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements
Characteristics of applicant:
- Passionate about TeVido’s mission
- Ability to work in a dynamic environment with minimal supervision and easily adapt to changes in schedules and priorities
- Ability to communicate and collaborate effectively with colleagues
- Shows initiative and seeks to contribute to other areas of company when appropriate
Please send resume to firstname.lastname@example.org