Engineer # JN -072021-67900

 Description:

• Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related projects in the Process Development Organization, within the Final Product Technologies (FPT)
• This candidate will be a part of the Mechanical Engineering Methods team which, in addition to lifecycle management of Physical GMP Test Methods, manages lifecycle of integrated testing machines and develops and validates test methods
• Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation
• The candidate will work cross-functionally to help the team make use of automatic data transfer between various systems
• Assist with project definition by performing engineering studies and assessment for automation system installations
• Perform field evaluations of existing systems and provide engineering design recommendations
• The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology
• The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions
• This may include, but is not limited to, the following:
  • Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols
  • Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation, IQ/OQ, Gauge Repeatability and Reproducibility
  • Troubleshooting of various lab instrumentation and automation, which will require learning the specific software controlling the instruments and integrated systems from vendor manuals, and site documents
  • Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
  • Optimizing workflows and protocols to increase throughput, improve data quality, and/or reduce consumable consumption
  • Developing, enhancing, automating, and managing test data
  • Network with manufacturing and quality organizations internal to Organization
  • Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
  • Monitoring technological developments in the field & evaluation of new technologies

Preferred Skills

• Experience working in a regulated industry, exposure to GMPs
• Knowledge on coding and/or configuring of PLC control systems and laboratory measurement systems
• Knowledge on databases like SQL/spark SQL and ability to manipulate large datasets from various source systems/databases or configuring and use of Data Historians (OSI PI )
• Knowledge of at least one programming/scripting languages (Python, Java, C++, MATLAB, or R) to create macros and tools to automate repetitive tasks
• Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership 

Preferred Traits:

• Passion for proactively identifying opportunities through creative data analysis and modeling
• Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
• Ability to manage multiple, competing priorities simultaneously

Education:

• Master’s degree in engineering
• Or Bachelor's Degree and 2 years of engineering/scientific experience