OctoPlus
Leiden, Netherlands
Job Description
As an engineer you are a member of the formulation and process development group at OctoPlus. You participate in project teams in which you are lead the development of robust, scalable and scaled-up processes for complex pharmaceutical formulations. You set-up process parameter investigations on a lab-bench scale to obtain knowledge on critical process steps. You select appropriate equipment available at the market, or you design custom made equipment. Furthermore, you design large scale processes comprising multiple unit operations often conducted aseptically and according to cGMP. You communicate with our in- and external customers on plans and progress. You collaborate not only with direct colleagues but also with analytical developers, technology transfer officers and technicians. You advice business development and project managers on the approach and planning of process engineering activities. You assure an up-to-date knowledge level by following the latest advances in the field of process engineering.
Responsibilities:
- Design processes from laboratory to large scale multi-step aseptic processes that are competitive and meet all GMP requirements;
- Improve processes and trouble shooting;
- Plan, set-up and execution of process investigations within project scope;
- Assure proper selection or design of equipment;
- Communicate cleary and timely to our in- and external customers on project progress;
- Maintain quality of reports with accurate data and conclusions;
- Give technical advice during acquisition of a project and help with an acquisition proposal writing;
- Interface with engineers, technicians, customers and suppliers providing training and technical support as needed;
- Contribute in knowledge sharing in - and outside OctoPlus;
- Advise on efficient experimental approaches custom to the projects;
- Assist in transferring manufacturing processes and products to production floor by providing draft batch records, training operators on new equipment. Provide support during the start up to assist them in learning new process.
Profile
You are a senior engineer with a proven track record in the pharmaceutical industry with focus in process development and engineering support for the formulation of new products. You have a strong understanding of cGMP required to guide the compliance of developed procedures. You have accomplished abilities in the area of training and implementing lean manufacturing principles, generating tangible savings and providing customer satisfaction in quality and delivery. You are pro-active, accurate, and goal oriented. You are expert in chemical engineering and process development, yet you can deal with a variety of disciplines easily. You have excellent capabilities in communication both in- and externally. You are flexible, service oriented and you have a problem-solving attitude. Working in a challenging dynamic and industrial environment for you means to set-up a manufacturing process according to pre-set timelines with high quality output.
Background
You have a MSc. or PhD. in chemical engineering, process engineering reactor engineering, particle design, pharmaceutical or food technology. You have at least 10 years industrial experience in development of aseptic pharmaceutical processes, preferably emulsification processes. You have experience with P&ID, PFD, PAT, DoE and QbD. You have experience in process validation and working according to Good Engineering Practice. You have affinity in working in a multidisciplinary and commercial environment.