Sr Principal Engineer - Formulation & Material Prep

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.

Organization 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.

Position Description:

The Principal Process Engineer for Cleaning/Sterilization and Formulation role is a technical position that supports the asset delivery, process development, commissioning, qualification, validation, and startup of the associated processes and equipment in the Parenteral manufacturing area. The Principal Engineer will lead the area of equipment prep and formulation and become the lead SME in the area. Primary objectives include the start-up and compliant manufacturing of RTP products, particularly as it related to development and implementation of process strategies, partnering with other areas to develop and implement validation strategies, and other related activities.
 

Responsibilities:

• Provide technical support for all start-up activities related to formulation of drug product, temperature mapping, cleaning and sterilization programs.
• Assist in the development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, parts washers, autoclaves)
• Provide technical guidance to the Process Team for cleaning and sterilization processes.
• Lead and/or provide technical support for root cause investigations related to process equipment
• Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Participate during internal and external audits, including regulatory inspections, as needed.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, commissioning and qualification test cases, process changes etc.
• Work within or lead cross-functional teams in a positive fashion to implement Process Engineering objectives and deliver on business plan and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and teams to ensure harmonization across platform
• Build and drive safety and quality culture within organization
• Provide technical support in terms of SOP approvals, verification and design documents reviews and approvals, and on-field support as required
• Ensure equipment is properly maintained in a qualified state for reliable supply of medicine
• Lead and implement continuous improvement projects or troubleshooting initiatives within the Formulation and Equipment prep workstream

Basic Qualifications:

• Bachelor's degree in engineering
• At least 5 years of automation and/or engineering experience.
• Excellent interpersonal, written, and oral communication skills.
• Strong technical aptitude and ability to train and mentor others.

Additional Skills/Preferences:

• Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
• Previous experience with highly automated equipment.
• Previous Experience with Parenteral systems specifically RS Batch oriented formulation systems, and filling systems.
• Previous facility or area start up experience.
• Previous equipment qualification and process validation experience.
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Previous experience with deviation and change management systems including Trackwise.

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Additional Information:

• Ability to work 8-hour days – Monday through Friday
• Ability to work overtime as required

For internal employees, if you are currently in a technical path role, but outside of the posting band, you may apply. You will be hired at your current level. For example: Current P4 (tech ladder), Posting R1-2 tech ladder, hire will occur at P4 

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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 (subject to applicable law).