Just – Evotec Biologics is seeking a highly motivated and creative Process Engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. The new Engineer will join a fast-paced, collaborative, and multidisciplinary team responsible for the manufacture of mammalian cell-based biotherapeutics for clinical use.
The focus of this job is to execute manufacturing operations while ensuring cGMP compliance. This will include set-up, operation, and maintenance of disposable-based manufacturing equipment while under direct/moderate supervision. As the successful candidate develops, additional job responsibilities may include troubleshooting and/or providing technical expertise during investigations, ensuring training compliance, as well as developing and maintaining manufacturing and technical documentation. The candidate will be expected to follow written procedures for safety requirements, cGMP practices, Standard Operating Procedures, and manufacturing documentation.
The staff member may also contribute to aspects of technical operations and technology transfer; support new product introduction; participate in the evaluation of new manufacturing technologies; and provide key input to multidisciplinary project/technical teams. As a member of the cell culture group, the successful candidate will have an understanding of upstream processing, including single-use bioreactor operations and perfusion technology.
Qualifications and Education Requirements:
- Bachelor’s degree in biological or engineering science with 0-3 years relevant experience
- Understanding of upstream processing including single-use bioreactor operations and perfusion technology
- Basic knowledge of biologics manufacturing process equipment and automation systems
- Candidate must possess strong focus on quality and attention to detail
- Possess effective time management and organizational skills
- Capacity to develop solutions to technical issues of moderate scope
- Ability to organize, analyze/interpret, and effectively communicate results
- Motivated, self-starter with strong mechanical aptitude
- Good interpersonal, team, and communication skills are a must
- Excellent oral and written communication skills
- Experience with upstream disposable manufacturing technologies from bench-scale through commercial scale is a plus
- Knowledge of cGMP requirements to ensure compliance
- Understanding of change control, NC/CAPA, and deviations
- Basic understanding of process automation (DeltaV) is a plus
- Experience applying knowledge and expertise to solve complex technical problems; may apply novel approaches that provides significant technology advancement
- Ability to work independently or in project teams
- Experience in technical projects with collaborators and vendors