Process Development Engineer II - Part-time 20 hours

Job description

Purpose and Scope Performs the design and implementation of aseptic manufacturing processes, instrumentation, and equipment for product technical transfer to commercial manufacturing scale-up. Provides support for existing commercial products/processes when needed. Develops and recommends new process technologies to achieve improved product quality and cost effectiveness. Essential Duties & Responsibilities: - Collaborate with the formulation team to develop and improve manufacturing processes for new and existing products. - Conduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new sterile products. - Interface with equipment vendors to specify equipment, request quotes and order equipment. - Write protocols, reports, batch records, procedures, and other controlled documentation. - Develop and perform process validation and write validation reports. - Develop cleaning processes and perform cleaning validation. - Provide hands-on execution of engineering studies and manufacture of clinical trial batches. - Understand cGMP requirements and collaborate with Quality Assurance, Validation and Regulatory to ensure compliance. - Experie...