Sr. Process Engineer

2 months ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

At Lilly, we are dedicated to combining compassion with innovation to enhance the quality of life for individuals worldwide. As a prominent player in the global healthcare arena with its headquarters situated in Indianapolis, Indiana, we are steadfast in our mission to uncover groundbreaking medications, further the comprehension and handling of illnesses, and contribute to society through charitable endeavors and volunteering. Placing a paramount focus on people, we are on the lookout for individuals driven to positively impact lives across the globe.

About the Job and the Company:
Lilly's Bioprocess Development (BR&D) division is currently seeking a dynamic candidate for a pivotal role within the organization. The successful applicant will take charge of overseeing equipment in the K360 Clinical Trials Manufacturing Facility, collaborating with both the development and operations teams to facilitate tech transfer activities and acting as the primary liaison for addressing equipment-related issues.

Responsibilities:

The bioprocess pilot plant at Lilly accommodates a varied range of stainless steel and single-use equipment to facilitate diverse clinical trial manufacturing procedures. The incumbent will offer engineering assistance to the maintenance and operations units as necessary to sustain the production of Bulk API for developmental and clinical trial applications. Key responsibilities include:
  • Providing engineering support within the pilot plant, including troubleshooting process and equipment challenges, overseeing process equipment change controls, and leading investigations into process and equipment deviations
  • Evaluating impacts and risks associated with new processes and unit operations concerning existing equipment
  • Ensuring compliance of processing equipment with PR&D Quality System stipulations, relevant engineering standards, and cGMP mandates
  • Supplying engineering insights and equipment expertise for the seamless tech transfer of new processes from the development phase
  • Actively monitoring processes during ongoing campaigns
  • Offering process engineering design expertise for chromatography columns and buffer delivery systems
  • Furnishing process engineering support for the commissioning and qualification of novel equipment or re-qualification initiatives as needed
  • Identifying and implementing opportunities for process enhancement and operational efficiency
  • Engaging proactively with various departments such as HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing
Basic Qualifications:
  • Hold a BS or MS in chemical engineering, biological engineering, or a related field, coupled with at least 2 years of hands-on experience
  • Demonstrated experience in large-scale column chromatography
Preferred Skills:
  • Proficiency in operating UNICORN Software
  • Background in GMP biopharmaceutical manufacturing environments
  • Over 3 years of experience in biopharmaceutical production unit operations supporting antibody or protein purification processes
  • Comprehensive understanding of process control systems
  • Strong problem-solving capabilities
  • Excellent verbal and written communication skills suited to diverse audiences, ranging from operational staff to management
  • Ability to function effectively within a team environment encompassing diverse functional relationships and a willingness to assume accountability
Additional Details:
  • This position is based at Lilly Technology Center North in Indianapolis, IN
Eli Lilly and Company, along with its affiliates, are dedicated to fostering an inclusive work environment that empowers individuals with disabilities to actively participate in the workforce and ensures equal job opportunities for all. Should you require accommodations to apply for a position at Lilly, kindly reach out to Lilly Human Resources for assistance. Please note that this email address is designated solely for accommodation requests during the application process; all other communications will not elicit a response.

Lilly upholds an Equal Employment Opportunity and Affirmative Action policy, refraining from discrimination based on age, race, color, religion, gender, sexual orientation, gender identity, nationality, veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) furnish robust support networks for members and aid in nurturing talented individuals for future leadership roles within our organization. Presently, our array of groups includes the 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, and Working and Living with Disabilities. Explore further insights into our diverse groups.

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