An engineering professional who, working with little or no supervision, applies advanced scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete complex assignments related to one or more technical fields or disciplines. Contributes to the development of new principles and concepts
Key Responsibilities Include:
- Leads computational fluid dynamic (CFD) with modeling responsibility to support the predictive manufacturing process from lab, pilot and up to commercial scale of pharma drugs, parenterals and combination products.
- Conducts freeze-dry modeling to support with lyophilization process and scale up of manufacturing process from lab, pilot to commercial scales of protein-based and small molecular formulations.
- Supports modeling development to predict freeze-dry cycle performance under various process conditions for different drug products to enhance product quality and improve manufacturability.
- Performs engineering analysis by using heat and mass transfer for the lyophilization process with experiences in different freeze-dryers and support analytical techniques.
- Analyzes the modeling outcome and provide scientific explanation and justification of results based on the generated data from modeling and analysis.
- Partners with team members to ensure all objectives are met; supports team to design and develop freeze-drying process of the critical process wetting and product parameters.
- Prepares study design and provides written, verbal deliverables, reports and presentations for management and stakeholder reviews during the progress and at the project final conclusion.
- Assumes CFD responsibility to include compliance with required quality and regulatory to assure practice of the developed models fulfilling all essential standards internally and externally.
- Participates in various scientific and technical presentations, discussion and communication; summarize key observation to support the project team for decision making.
- Responsible for compliance with applicable Corporate and policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fallback strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes. Mitigates risk within functions through sound design, early risk assessments and implementation of fallback strategies.
- Identifies, plans, and conducts medium- to large-size projects across engineering disciplines requiring custom, risk-managed execution plans, investigations, and/or equipment. Makes difficult decisions regarding priorities between projects. Responsible for achieving the project's financial targets in support of business objectives and life cycle costs.
- Experience and knowledge of fluid dynamic analysis in heat transfer (conduction, convection and radiation), mass transfer and momentum transfer for scientific problem solving and its associated materials knowledge of the subjects of applications.
- Training at graduate / postgraduate degree in mechanical engineering, chemical engineering, aeronautics and astronautics engineering, mathematical engineering, biomedical engineering, pharmaceutical sciences, physical chemistry, or other relevant degree with.
- Experiences in employing computational fluid dynamic (CFD) engineering and tools to develop and apply modeling and simulation to determine air, fluid, thermal analysis, involved in fluid flow, aerodynamic system, aerothermal environments, and flow field to support conceptual design, detailed design and analysis, and cutting edge research. CFD tools requires interface with structures and thermal modeling tools.
- Experiences in drug product Lyophilization process (freeze-dry) and its related modeling process to support the commercialization process from lab, pilot to commercial scale manufacturing. Enable to employ laminar flow and turbulent eddy flow simulation or fluid-thermal-structural interactions of freeze-drying process systems.
- A M.S. in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated CFD competence, with a desired 10+ years of significant engineering and/or operational experience. A Ph.D. education/degree is desired, and may contribute towards the desired years of experience.
- Has demonstrated excellence in breadth and depth within CFD discipline and across disciplines.
- Has a career history marked by a consistent series of CFD technical contributions and accomplishments. Significant contribution to pharma drug product or process development or improvement through creative application of technical effort will equally be recognized.
- Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions.
- Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
- Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
- Works well with other engineers in a collaborative, fast-paced goal-driven environment.
- Possesses interpersonal skills to negotiate and reconcile differences.
- Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
Equal Opportunity Employer Minorities/Women/Veterans/Disabled