Process Engineer IIICellectis • Raleigh, NC, United States

Process Engineer III

Cellectis • Raleigh, NC, United States

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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

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.

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