Senior Process Engineer

Job Description

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 35,000 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.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. We are looking for Senior-level Process Engineers in the Parenteral (formulation, filling, and vision/inspection), Device Assembly, and Packaging spaces.

Responsibilities:

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. We have several current and future opportunities as Process Engineers in both the Parenteral and Device Assembly/Packaging space. This role will be part of the RTP Site Engineering team.

In, addition you will have the following Key Objectives/Deliverables:

• 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.
• Take overall responsibility for the safe design and safe operation of the equipment within the area.
• 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.
• Lead troubleshooting efforts to resolve more difficult equipment and operational problems.
• Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve equipment issues.
• Respond to and implement customer requests related to the equipment.
• Communicate effectively with others, especially process team members, customers, engineering tech, and crafts personnel.
• Evaluate all activities for impact on qualified state of equipment and utilize appropriate tools/processes as necessary (change control, hold, etc.).
• Responsible for system/component classification and maintenance strategy for equipment.
• Implement corrections, corrective actions, and countermeasures arising from CAPA’s.
• Participate in Periodic Reviews for equipment.
• Lead or participate in IQ/OQ/PQ activities (including commissioning activities of new equipment or areas).
• Develop scope for capital projects targeted at both short- and longer-term needs.
• Act as user representative for capital projects or delivery agent for local projects.
• Understand equipment reliability issues with the objective of improvement.
• Coordinate with site/corporate asset management personnel to replicate improvements and assure alignment of maintenance and other equipment activities.
• Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within the area.
• Compare equipment performance data with that of other operations to determine areas of opportunity.
• Goals/objectives should target world-class levels of operation for safety, quality and customer service.

Minimum Requirements:

• Bachelor’s degree in Engineering
• 5 or more years in cGMP manufacturing or manufacturing support experience
• Adequate interpersonal and communications skills to be able to work effectively in a team-based environment.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Skills/Preferences:

• Exposure to parenteral processing equipment and operations including formulation, filling, freeze drying, visual inspection, and isolation equipment.
• Exposure or Front-line support to aseptic filling lines
• Demonstrated ability to solve technical problems and implement projects.
• Strong interpersonal and communication skills
• Project management experience.
• Ability to work effectively with outside suppliers
• Knowledge of C4I and LEAN methodologies
• Excellent verbal and written communications skills
• Strong problem-solving skills
• Strong Mechanical Aptitude
• Professional Engineering (PE) License desired but not required.

Additional Information:

This position will be based out of our Raleigh, North Carolina plant (RTP). Schedule - 8 hour days - Monday through Friday, overtime and some weekend/holiday may be required for project support.

Travel - Domestic and International travel may be required (20%)

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at [email protected].