Responsibilities :
- Applies engineering expertise to process engineering projects in support of process development, process transfer and clinical / commercial manufacturing, including processing equipment and system design, procurement, installation, and support.
- Provides process engineering direction for a product, including scale-up approaches and process performance corrective actions in manufacturing.
- Owns process technology for a unit operation, including scale-up and best-practices to ensure stable and reliable performance at manufacturing scale.
- Authors, reviews and approves basic to complex technical documents including product impact assessments, product campaign summaries, equipment validation, and process technical transfer documentation.
- Provides comprehensive biotech unit operation expertise and problem-solving skills requiring the advanced application of engineering theory and the use of creative skills in developing hypothesis.
Working knowledge of process validation approaches. Applies a working knowledge of engineering standards for equipment design, implementation, and operation.
- Works independently to solve complex or novel problems requiring advanced engineering approaches. Supervision and guidance relate largely to overall objectives, critical issues, new concepts and policy matters.
- Leads cross-functional projects of moderate scope. Guides the successful completion of major programs (e.g. Tech Transfer).
Requirements :
- Ph.D. in Engineering or B.S. in Engineering with 6 years of relevant experience. Candidate requires strong understanding of bioprocessing equipment design principles.
- Language Ability : The candidate will need to be able to write up and present process development and manufacturing results in a clear and concise manner.
- Reasoning Ability : The candidate requires a strong understanding of biochemical engineer principles and the ability to apply these principles to biopharmaceutical processes.
- Math Ability : The candidate requires a demonstrated grasp of basic engineering mathematics.
- Physical Demands : This position involves predominantly office duties, although some lab and plant support work (
- Equipment Use : Computers. A basic understanding of bioprocess equipment is required.
- Working Conditions : Occasional direct plant support that may occur 24X7 (limited to standard durations, may or may not be scheduled in advance) and support over holidays.
Pay Range : 100,000 115,000
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range.
KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
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