Process Engineer III

Job Description

The Process Engineer III will be responsible to provide specialist knowledge and expertise, as Subject Matter Expert (SME), of specific cell and gene therapy processes and / or process technologies. This position will also oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

Position Responsibilities

• Owning the knowledge of specific cell and gene therapy manufacturing process technologies, locally
• Participating in the definition and selection of cell and gene therapy manufacturing equipment, through providing input to User Requirements
• Supporting, as technical expert, the Validation manager in the design of Process, Equipment and Computer Systems validation within their SME area
• Collaborate with process development, other sites and global teams to facilitate transfer of technical knowledge
• Provide support and technical know-how to the Manufacturing Team in support of ongoing technical transfer and manufacturing operations
• Be a recognized scientific expert internally and externally by reporting and presenting technical work at internal / external meetings / conferences
• Maintain their work in inspection readiness level
• Support writing of Quality Risk Assessments for existing and new / changed processes
• Support creation of SOP's for MS&T and Manufacturing
• Provide technical expertise to Engineering for design activities in Capex projects and technologies within their area of expertise
• Provide technical expertise for validation activities around processes / technologies within area of responsibility
• Site point of contact (SPOC) for technical transfer activities of cell and gene therapy manufacturing processes into or out of the site
• SME for cell and gene therapy manufacturing processes following product / process transfer
• Harmonize and optimize technical processes across the site
• Benchmark new technologies and equipment relevant for site
• Designs and controls optimization projects
• Provide SME expertise to perform process characterization of the related cell and gene therapy processes to increase robustness and sustainability
• Support manufacturing operations in trouble shooting / root cause investigation by providing second level of specialist expertise as SME and if needed, liaison with Process Development for additional expertise
• Perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies
• Provide technical trainings and education programs for site as needed, production operators in particular
• Indirect management of small to mid-sized project teams including multi-functional process introduction / improvement projects
• Identifies, executes, measures, monitors and reports key MS&T metrics, requirements and infrastructure for sustainable process monitoring
• Participates actively with MS&T Team to establish the MS&T annual goals and desired culture
• Gathers on-going industry knowledge and stays abreast of new developments in the industry and in governmental regulations
• Travel up to 10% of the time
• Such other responsibilities and duties as the Company may from time to time assign

Education and Experience

Technical Skills / Core Competencies