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.

POSITION BRAND DESCRIPTION:

The position of Senior / Principal Process Engineer - APIEM [ Synthetic Peptide Synthesis and Purification / Small Molecule ] reports to the Associate Director - Engineering API EM and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always by:

• Developing and sustaining process knowledge in order to ensure the execution of the the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs).
• Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy.
• FUME assessment to ensure an understanding of risk presented to the operational control strategy.
• Participation with internal or CM resources in the equipment specification, procurement, and IQ/OQ/PQ.
• Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products.
• Engaged with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets.
• Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs.

DEVELOP AND SUSTAIN PROCESS KNOWLEDGE

• Identify process knowledge gaps that impact equipment and process capability.
• Develop or support the capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, process modeling, and equipment design basis).
• Enable the development and maintenance of process knowledge. infrastructure such as key models, report history, lab models, and literature.
• Utilize optimization resources and tools for process analysis and process improvement studies.
• Review and track key process engineering metrics.

BASIC REQUIREMENTS:

• 3 years of work experience in a GMP manufacturing/process engineering related role
• Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations.
• Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
• Demonstrated ability to function in a team environment as a technical leader and as a member of teams.
• Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.

EDUCATION REQUIREMENTS:

• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive GMP chemical manufacturing experience.

Please refer the Job description for details