As Process Engineer, you will be responsible for an assigned process (or sub process). For an existing process this means that on-going process data should be gathered and analyzed, deviations need to be investigation for potential product impact, changes should be evaluated prior to implementation and data gathered post implementation to prove that the change had the desired effect. For new processes it means that the (small scale) developed process needs to be evaluated and the changes required for the robust and compliant implementation of the process are defined precisely. The process engineer needs to work closely within the Technical Transfer team to ensure that the development knowledge is accurately transferred into the operational documentation. In both situations you will work closely with the manufacturing specialists (system owners), operators, GMP specialists, Quality department and the process development group. The process engineer must be a Subject Matter Expert (SME) and needs to be up to speed with all developments internally as externally on the process.
As Process Engineer, you will be responsible for:
- Ensuring that the implemented process is well defined and aligned with the operational procedures.
- Supporting production of cGMP batches. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
- Taking the lead in root cause investigations of complex deviations where there is (potentially) significant product impact and for the implementation of preventive actions.
- Initiating and handling of compliance records (change control, events, CAPA, deviations).
- Conceptualizing (process) improvements, define scope and deliverables, lead a team to implement agreed change and realize the agreed goal.
- Having the overview and knowledge of the status of the process (e.g. stability of critical parameters, ongoing investigations, registered process) • Identifying and participating in improvement projects to increase the speed, reliability, yield or capacity of the process.
- Leading process excellence activities to continuously improve the work as well as personal skills.