Engineer Process Sciences (fixed duration employment)

Company Name:
Eli Lilly
This position is responsible for the technical support of manufacturing operations. This position will interact with engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. Interaction may be required with other Lilly site / contract producers of ImClones products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required. This position may also include responsibilities for the development and technical support of Manufacturing Technology data analysis and visualization tools and applications. Database experience a plus.
Responsible for supporting manufacturing operations through the performance of the following duties:
Trends and analyzes production data.
Troubleshoots issues in conjunction with manufacturing staff.
Communicates issues in a timely manner.
Assists in the transfer of processes and process improvements from process development to production facilities and from one production facility to another, anticipating and addressing scale-up issues.
Authors technical reports supporting technology transfers, deviation/adverse event reporting and process analyses/trending.
As required, develops data visualization or data archival tools that support new databases or laboratory equipment
As required, maintains database related tools and applications
Writes standard operating procedures as they relate to the activities of the Process Sciences group.
May assist with review of documentation in other departments within Manufacturing.
As required, works directly with the Manufacturing staff on the manufacturing floor to gather and understand the data being collected.
As required, designs laboratory experiments in support of process troubleshooting and/or process improvement and executes or coordinates execution in outside laboratories.
Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment.
Helps to define and implement control strategies for ImClone processes.
As required, assists in the planning and execution of process validation activities.
May be asked to collaborate on additional projects in Manufacturing Support & Process Validation Group As required, optimizes and enhances the existing data visualization tool set available in Manufacturing Technology
Executes validation protocols as required. Ensures cGMP compliance.
Basic Qualification:
B.A./B.S. in Engineering, Chemical/Biochemical Science, Computer Science or related field with 7 or more years industrial experience, preferably in a GxP regulated environment.
Fewer years will be considered depending on relevance of experience or an advanced degree.
Qualified candidate must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.
Additional Qualifications:
Database experience is a plus, object-oriented programming experience is desirable SQL knowledge is desirable
Process validation experience is a plus
Experience in fermentation/cell culture and/or protein purification manufacturing
Process and equipment knowledge of cell culture and purification functions.
Thorough understanding of GMP requirements for a large scale manufacturing facility.
Ability to learn and apply new software tools and programming languages when required to complete project assignments.
Demonstrated excellent communication skills, both oral and written
This position is not permanent. It is for a fixed duration for up to 4 years.
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