Advisor-Parenteral Filling 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. Were looking for people who are determined to make life better for people around the world.

At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

Path/Level:

R5

The Delivery, Device and Connected Solutions (DDCS) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems including medical devices and container closure systems.

We are seeking an Advisor in the area of parenteral filling process engineering to be a key contributor within our Parenteral Packaging team within DDCS Packaging Organization, offering advanced technical expertise in the field of filling process for parenteral packaging and Lillys combination product. This role demands leadership in the development of filling process and associated equipment and suppliers, working collaboratively with CMC, device design, manufacturing and quality teams to ensure successful development and commercialization of Lilly drug products.

As a vital contributor to CMC success, the candidate must be knowledgeable, highly energetic, and self-motivated. The person must distinguish him- or herself through capability, efficiency, safety and continuous advancement in aseptic filling process and associated parenteral packaging area.

The key responsibilities and deliverables are:

• Lead parenteral filling process development projects for container closure systems, including vials, prefilled syringes and cartridges, throughout Lilly's new drug product development cycle for commercialization.
• Perform filling process development and machineability assessment through hand-filling lab instrument, semi-automated pilot line, automated flexible lines and small volume lines, and fully automated high-speed commercial filling lines.
• Work closely with parenteral packaging engineers to prepare drug or placebo-filled samples for container closure suitability assessment, system qualification and regulatory filing.
• Collaborate closely with Lilly internal cross-function SME including Biological Formulation and Process Development, Clinical Trial Operation, DDCS Device Design and Development, Commercial Engineering, Procurement, and Quality to support due diligence team on selection for Contract Development and Manufacturing Organizations (CDMOs), and fill-finish equipment manufacturers (OEMs) for Clinical Trial.
• Manage equipment vendors including project execution and on-site testing.
• Partner with Lilly SME, external parenteral packaging component or product suppliers, CDMO and OEMs to develop a de-risked and viable pathway of filling equipment and process for clinical trial and potential commercial manufacturing.
• Support or draft, as needed, technical protocols and report for the development of parenteral drug product process
• Develop deep understanding of equipment flow chart/process flow document, critical process parameters, and create an instruction for the process and equipment operation
• Work with TS/MS SME and statistician to develop filling control strategy, and support tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
• Drive initiative to explore state-of-the-art technology to advance effective business solution to improve quality of product, accelerate timeline to deliver, and teams capability.
• Pharmaceutical primary packaging selection, assessment and qualification
• Ensure a safe working environment by following safety rules and helping improve the safety culture.
• Actively participate in safety-related activities (audits, JSAs, hazard reviews, etc.) to drive ongoing safety improvement
• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP policies and procedures.
• Support team, department, and corporate initiatives and due-diligence activities relevant to packaging solutions through deep and pertinent technical input.
• Enhance Lillys professional image and competitive advantage through presentations, external conferences, publications, and other professional activities

Basic Qualifications:

• Bachelor degree with 8+ years of experience, or Master degree with 5+ years of experience, or PhD degree of 3+ years of experience in chemical, materials, biomedical engineering or related fields.
• Expert knowledge in parenteral filling process and handling of sterile single-use components for various container closure systems in drug product aseptic filling applications.
• Previous experience with equipment and equipment vendors for parenteral filling process
• Ability to multi-task, adapt to changing priorities, and work in a fast-paced environment.
• Ability to work in a safe manner to ensure the safety of self and others.
• Must be a self-motivated individual requiring little oversight on day-to-day activities.
• Travel is part of the job, may be up to 25%; must be able to travel within domestically and internationally.

Additional Skills/ Preferences

• Previous pharmaceutical primary packaging selection, assessment and qualification experience is highly preferred.
• Previous experience with combination products, drug delivery device, and container closure system.
• Familiarity with Quality By Design (QbD) and ICH guidelines
• Experience in working effectively with cross functional groups
• Solid understanding of basic requirements of regulatory agencies
• Demonstrated ability to influence and operate cross-functionally.
• Coaching and mentoring junior engineers

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 ( ) 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), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidates 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 Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly