Process & Design Engineer II – Aseptic Processing
You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.
The candidate should have deep knowledge and experience in one of the following areas:
1. Aseptic Processing and aseptic process design (sterile filtration, CIP/SIP)
2. High pressure homogenization/micronization experience
3. Powder handling and processing, milling and drying
• Bonus Tech Transfer
This position is responsible for supporting the development of manufacturing processes for complex parenteral formulations through process design, equipment specification and procurement, and equipment and process qualification. This position provides technical support in developing and optimizing cGMP manufacturing operations for complex parenteral formulations, including providing engineering support for the safe handling of high potent active pharmaceutical ingredients, and is responsible for the preparation of process and equipment documentation (e.g. PFDs, URSs, EAFs, ETOPs, IQOQs, etc.).
This individual contributes to engineering aspects of product and process development as well as to process trouble-shooting and optimization using a methodological approach (e.g. risk assessment, root cause analysis, Quality by Design, Design for Six Sigma, Lean Six Sigma, etc.). This position can serve as the technical lead for internal and/or customer projects or sub-projects. In addition, the individual can train and support other engineers, scientists, laboratory technicians, and co-ops on equipment operation and usage.
- Provide engineering support for process development and optimization on customer projects
o Support the design, procurement, and assembly of process equipment sets, and author and review process and equipment design documentation
o Design and execute development batches in support of pharmaceutical formulation research and development, engineering design, development, and scale-up, and cGMP manufacturing operations
o Maintain thorough and accurate research and laboratory documentation including experimental methods, observations, data, and results
o Support and/or drive the following activities within the
-Risk management (ICH Q10, safety and quality risks,
-FMEA, equipment risks, process risks)
-Root cause analysis (ABS toolbox, Ishikawa, 5 Why) and identification of engineering and scientific solutions
-Data collection, storage and statistical analysis of data (ANOVA, hypothesis testing, correlation and regression analysis) and identification of appropriate actions
-Process design and improvement using QbD, LSS and
DfSS principles (e.g. SIPOC, FMEA, criticality analysis)
-Process GAP analysis and mitigation during process development and scale-up (e.g. mixing design, fluid transport, drying, etc.)
o Interact and communicate effectively with project teams, consultants, management, and clients
- Process and Equipment Improvement and Optimization
o Actively seeking and identifying opportunities to improve processes, equipment designs, and procedures; takes corrective action independently
o Recommends improvements in intra-departmental workflows, as required e.g. scale-up approach, development framework
o Optimize development and production processes for both client projects and internal projects
o Contributes actively to increase process understandings and process control improvements on projects and in general
o Contribute to the development of novel and proprietary technologies, methods, and Intellectual Property.
- Leadership and training to advance internal projects and individuals
o Train other department members on the usage of equipment, the development process, documentation and tools and methodology to support the development process
o Lead internal projects (continuous improvement projects, I2P projects, engineering projects)
- Other Responsibilities
o Follow safety practices and procedures; use personal protection equipment (PPE) appropriate to the type of hazard and exposure potential. Actively participate in identifying and resolving safety issues
o Provide support for PHAs and proper process safety design
o Follow cGMP regulations and procedures; generate and maintain thorough and accurate documentation in support of cGMP regulated activities
o Identify continuous improvement opportunities in documentation, quality, safety and daily operations and execute tasks and/or projects on gap closure or improvements
o Maintain and increase current scientific knowledge through review of current scientific literature and develop appropriate ways, methods and tools to do so
- Three (3) or more years of directly related experience in process development is required, pharmaceutical experience preferred, experience in aseptic pharmaceutical manufacturing or development is a plus.
- A minimum MS in a relevant engineering field (e.g. pharmaceutical engineering, chemical engineering); or a BS in a relevant technical field with a sufficiently demonstrated level of performance and capability, as determined by management.
- Experience in aseptic processing and aseptic process design, high pressure homogenization and/or powder handling
- A plus is experience in Drug Delivery and Encapsulation Technologies (formulation & process) (Microparticles, Nanoparticles, Liposomes, Nano-suspensions, Implants)