Senior Process Engineer

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Job Description

Our new RTP facility will be one of Lilly’s most technically advanced manufacturing sites and will include robotic technologies, and advanced data collection and analysis platforms that will result in safety improvements, increased productivity, and variability reduction. The Senior Process Engineer - Filling role will be part of the RTP Site Engineering team responsible for the delivery and process support of the Filling lines.

Key Objectives:

• Provide technical support for all start-up activities related to aseptic filling, aseptic practices, and decontamination cycle development and validation
• Provide technical support for root cause investigations related to Filling and other process equipment
• Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Support during internal and external audits
• Prepare, technical documents, as required, such as: change controls, commissioning and qualification test cases, process changes etc. 
• Lead and implement continuous improvement projects or troubleshooting initiatives within the Filling workstream
• Provide on-field support and remote support (as needed) to Engineering technicians and Maintenance technicians
• Provide technical mentorship to entry level Engineers, and Engineering technicians
• Perform Asset Qualification monitoring of Filling Assets in Process Engineering
• Lead commissioning and qualification activities during startup phase, and implement projects post qualification as needed
• Represent RTP process Engineering in the Global platform alignment meetings and provide technical input on discussions and network challenges as it relates to Pre-Filled Syringe Filling
• Ensure a safe working environment by following safety rules and helping improve the safety culture.
• Actively participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvement.
• Provide engineering expertise as active member of area process team.
• Obtain technical expertise of equipment and processes in area of responsibility. This includes clear understanding of equipment flow chart/process flow document, critical process parameters, and master formula instructions for the process.
• Establish & monitor/trend control systems as tool for verifying and optimizing equipment performance.

Requirements:

• Bachelor’s degree in Engineering
• At least 2 years of previous experience in pharmaceutical manufacturing

Preferred Attributes:

• Previous experience in area startup
• Previous experience in equipment qualification, cycle development, and validation.
• Previous experience with Aseptic Filling processes
• Ability to apply statistical thinking concepts to the analysis of manufacturing problems.
• Experience working with validated systems.
• Experience in utilizing root cause analysis techniques for the systematic solving of problems.
• Strong computer skills in a variety of software packages (Excel, JMP, etc.)

Additional Information:

• This role will work onsite at the Lilly RTP site in Durham, NC
• Travel up to 20% during Asset Delivery and < 10% after startup

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any