Process Engineer III

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

• BSc in Biology, Biochemistry, Chemical Engineering, or equivalent scientific degree.
• Minimum 7+ years’ experience in cell and gene therapy GMP manufacturing or 10 years’ experience in biologics/aseptic GMP manufacturing or a combination of thereof.
• Experience with process capability/control charts as well as using process statistical analysis software (e.g. Minitab or JMP).

Technical Skills / Core Competencies

• Proven ability to collaborate, establish relationships, build rapport with all stakeholders, and influence at all levels of management through informed discussions and presentations.
• Demonstrated ability to work under pressure, exercise sound judgement and analyze/resolve problems.
• Excellent verbal and written communications and presentations skills.
• Excellent MS Office (Word, Microsoft Excel, and PowerPoint) capabilities required.