The Process Chemist is a key role within the Engineering Department that supports, optimizes, and transforms internal manufacturing processes. This role works closely with the end-to-end manufacturing process on-site with Production and R&D scientists. As such, a significant portion of time (>30%) will be spent on the production floor and in collaboration with production chemists, scientists, technicians, and operators. In this role, the process engineer will develop into a technical subject matter expert related to all production processes.
1) Maintaining and providing technical support for processes throughout the manufacturing environment including filtration, cold storage, aseptic transfer, contamination control, mitigation, mixing, pooling, and sterilization.
2) Establishing equivalency when process and component changes are required to address supply chain disruptions, second and third-sourcing options, process efficiency improvements, batch scale-up, etc.
3) Provide technical rationale, root cause analysis, and devise corrective actions related to CAPA/QN/NCMR/CCI.
4) Identifying process improvements and "lean" opportunities throughout the Raw Material Processing and Formulation workspaces.
5) Ability to act as project manager, as necessary, to ensure initiatives are supported and completed in adherence to commitments.
6) Provide technical justification/rationale, strategy, and action plan to Design Review Board, as necessary, to ensure process improvement/sustaining initiatives are approved and implemented.
7) Effectively qualify/validate process changes following the Quality Management System requirements.
8) Collaborate effectively across multiple groups, including Production, R&D, Engineering, Maintenace, Quality
Bachelor’s degree in an engineering or life science field.
Previous experience as a process engineer/chemist within the medical device or pharmaceutical industries prefered