- Communication Skills
- Laboratory Experience
- Computer Skills
Applies engineering and computer expertise to process engineering projects in support of process development, process transfer and clinical/commercial manufacturing.
Job Duties Gather requirements, author technical documents, develop templates, and perform testing for the Electronic Laboratory Notebook / Inventory system. Leads and participates on cross-functional project teams or internal teams for incorporating ELN technology into work processes. Interfaces with various departments to ensure processes and designs are efficiently implemented in the Electronic Notebook System. Identify stakeholders, scope of work, and resource requirements required to identify and complete concept, feasibility, development, transfer and release phases of ELN templates. Write SOPs, Qualifications Protocols, and User Acceptance Tests to support change control records for the ELN system. Executes validation/qualification protocols, coordinates software upgrade/installs, trains staff, etc. Proactively investigates and identifies opportunities for improvement.
Develop and maintain plant simulation, process and unit operation models to aid PD in preparation for tech transfer of processes into manufacturing. Author Facility Fit/Process Transfer documentation describing how the process will be operated in manufacturing.
Computer Skills: This position requires strong computer skills. Basic programming experience (e.g. Matlab or Python) and database knowledge is preferred.
B.S. in Chemical Engineering or higher with an emphasis in biochemical engineering. The candidate should have at least 2-4 years of experience within a GxP setting.
Technical knowledge or expertise in development and implementation of biopharmaceutical processes.
Technical knowledge or experience using Electronic Laboratory Notebooks.
Experience with design of experiment, statistical analysis, and modeling preferred.
Self-starter with strong organizational, and general communication skills.
Comfortable working within a small, collaborative team
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.