Manufacturing Support Process Engineer

Raleigh, USA

The Manufacturing Support and Technology (MS&T) Process Engineer 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. They will also oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

The primary functions will be providing technical expertise in the MS&T group as follows: 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.

Published on November 12, 2019

RESPONSIBILITIES:

  • 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 SOPs for MS&T and Manufacturing
  • Provide technical expertise to Engineering for design activities in Capex projects around 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 process 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.

POSITION REQUIREMENTS:

  • BSc. in Biology, Biochemistry, Chemical Engineering, or equivalent scientific degree.
  • Desirable MSc. or similar advanced degrees/certificates
  • Minimum 5 years’ experience in cell and gene therapy GMP manufacturing or 10 years' experience in biologics/aseptics GMP manufacturing or a combination thereof
  • Experience with process capability / control charts
  • Experience using process statistical analysis software (e.g. Minitab or JMP)
  • Strong collaboration and ability to 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 judgment and analyze/resolve problems
  • Excellent verbal and written communications and presentation skills
  • Proficiency with MS Office