Sr. Principal Process Engineering SME, Parenteral

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.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The Engineering Tech Center is responsible for providing global technical expertise in the engineering sciences related to Process Engineering and secondary/tertiary loop disciplines.  This includes knowledge and stewardship of the following: First Principles, unit operations, Equipment Flow Diagrams, Capability Calculations, Material & Energy Balances, Facilities (fitness for use), Root Cause applications, Equipment and Unit Operation Changes/Improvements including new technologies, Scale-ups, Periodic Reviews, Process Safety, Maintenance/Reliability, etc.  This function has a global presence.  This team provides engineering support to global manufacturing sites for the customer network, Global Facilities Delivery (GFD), development sites, as well as external manufacturing organizations and alliances. 

This Aseptic Process Engineering position serves as a technical resource in Aseptic Processing and Parenteral Technologies such as Equipment Preparation, Formulation, Filling, Freeze Drying, and Isolation systems, providing expert process engineering support globally.  Parenteral sites supported include Indy Parenteral (IN), Fegersheim (France), Sesto (Italy), Suzhou (China), Research Triangle Park (NC), Concord (NC), Kenosha (WI), Alzey (Germany), and Lehigh Valley (PA).  This position also applies technical knowledge to effectively guide and support Lilly’s partner companies and contract manufacturers as well as mentor other engineers. 

Key Objectives/Deliverables:

• Technical and Discipline leadership –Partners with other technical staff to direct discipline activities, oversight of the community, new technology development and technology assessments, creation and maintenance of Engineering Standards, Master specifications and Best Practices for the discipline, and coaching and mentorship of junior engineering staff. 
• Safety and Compliance – Ensure personal and team compliance with all applicable regulatory and corporate policy requirements; ensure appropriate safety practices and procedures are in place and are followed to prevent injuries; ensures the ETC meets current Quality expectations and is a part of actively monitoring evolving Quality and other regulatory expectations related to engineering 
• Consultation - Assists sites globally with technical evaluations, master planning, technology assessments, and specific problem resolution including troubleshooting and root cause analysis 
• Knowledge sharing - Provides ongoing technical support to site engineering groups, domestic and global.  Serves as a mentor to Lilly engineers with a focus on technical development and functional capability building.  Interfaces with and develops site technical experts in Parenteral Engineering.  Reviews and prepares protocols and technical reports. 
• External Influence - Monitors and, when appropriate, influences change in external codes and standards on Lilly’s behalf.  Ensures external learnings are effectively communicated within Lilly and works to ensure ongoing compliance with these learnings. 
• Major Capital Support - Provides technical consulting and leadership, both conceptual and detailed design, to Global Facilities Delivery on major capital projects.  Will often lead multi-functional/multi-site project teams. 
• External Manufacturing Support - Provides technical consulting and leadership to Lilly’s external manufacturing partners.  Responsibilities will be range from due diligence, tech transfer, engineering batches to deviation investigation support.  Will work closely with cross-functional projects teams managing the relationships with our partners 
• Platform Owner – Provides Network technical leadership, oversight, and ownership for designated equipment platforms or processes.  Influences platform alignment across the Network to maximize project delivery, operational and maintenance efficiencies, and replicated cost benefits.  Develops strong relationships with our Original Equipment Manufacturers (QEMs) and leverages these partnerships as we develop new designs, trouble-shoot equipment issues and maintain our equipment. 
• Innovation - Investigates, develops, and integrates emerging technology and capabilities applicable to the Parenteral manufacturing process to meet production and compliance requirements. 

Basic Qualifications:

• Bachelors degree in engineering or related technical field. 
• Minimum 10 plus years in cGMP manufacturing or manufacturing support experience with increasing technical responsibility

 Additional preferences:

• Extensive knowledge of parenteral processing equipment and operations including formulation, filling, freeze drying, and isolation equipment. 
• Demonstrated ability to solve technical problems and implement projects. 
• Deliverables include input and support of facility design, equipment layout, technical specifications, and equipment optimization, testing and qualification. 
• Familiarity with technology advances in vial, cartridge, and syringe container closure systems. 
• Strong interpersonal and communication skills to be effective in a team-based situation.  
• Ability to work across boundaries (functional, geographic, external company, etc). 
• Demonstrated learning agility. 
• Ability to work effectively with outside suppliers. 

Additional information

• Business title is subject to change based on leveling.
• Must be able to travel up to 35% of the time with potential for more, US and international. 
• Role would be based at an existing Lilly Site and not eligible for remote work
• Potential for short term assignments (1-6 months) at Lilly or partner sites may be required including international.
• Will require occasional work in a variety of manufacturing environments; some safety equipment and/or gowning may be required.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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 other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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