Senior/ Principal Process Engineer

As a Senior / Principal Process Engineer - API at Lilly, your role involves providing technical leadership and expertise in conjunction with API EM Contract Manufacturer Personnel to ensure the reliable supply and commercialization of medicines with safety first and quality always. Your responsibilities include: - Developing and sustaining process knowledge to execute the appropriate product, process, and operational control strategy at Contract Manufacturers (CMs). - Direct and indirect interaction with CM personnel to ensure reliable supply through the execution of the operational control strategy. - Performing FUME assessment to understand risks to the operational control strategy. - Participating in equipment specification, procurement, and IQ/OQ/PQ processes. - Assessing HSE and PSM elements of CMs that impact Lilly products. - Engaging in developing capabilities with new technologies that may impact portfolio assets. - Adhering to the expectations of the Lilly Red Book in interactions with API EM's CMs. Your key objectives and deliverables include: - Coaching and mentoring Process Team Members. - Utilizing past experiences to provide insight and feedback to the Lilly / CM Joint Process Team (JPT). - Championing the application of statistical thinking for process monitoring and decision-making. - Supporting root cause analysis around incidents. - Identifying process knowledge gaps and enabling the development of key process knowledge. - Providing process and equipment support for production issues. - Supporting continuous improvement activities and cost reduction opportunities. - Reviewing equipment and process system requirements. - Serving as a liaison for HSE and PSM oversight at CM sites. - Ensuring adherence to Lilly policies and procedures. Basic Requirements: - 10 years of work experience in GMP manufacturing/process engineering. - Deep technical knowledge of API / Drug Substance manufacturing. - Ability to apply chemical engineering principles for process understanding and improvement. - Ability to function as a technical leader and manage competing priorities. Additional Preferences: - Experience in Small Molecule API manufacturing or Peptide Synthesis/Purification. - Experience in process hazard analysis and root cause analysis. - Strong computer skills in various software packages. Education Requirements: - Bachelor of Science degree in Chemical Engineering or another engineering discipline with GMP chemical manufacturing experience. Other Information: - Normal schedule is Monday-Friday, 8 hours/day with potential for teleconferences outside these hours. - International travel may be required. - Completion of assigned training curriculum. - Tasks may require entering manufacturing and laboratory areas with appropriate PPE. At Lilly, we are dedicated to providing equal opportunities for individuals with disabilities in the workforce. We do not discriminate based on age, race, color, religion, gender, or any other legally protected status. Join us at Lilly to make life better for people around the world. As a Senior / Principal Process Engineer - API at Lilly, your role involves providing technical leadership and expertise in conjunction with API EM Contract Manufacturer Personnel to ensure the reliable supply and commercialization of medicines with safety first and quality always. Your responsibilities include: - Developing and sustaining process knowledge to execute the appropriate product, process, and operational control strategy at Contract Manufacturers (CMs). - Direct and indirect interaction with CM personnel to ensure reliable supply through the execution of the operational control strategy. - Performing FUME assessment to understand risks to the operational control strategy. - Participating in equipment specification, procurement, and IQ/OQ/PQ processes. - Assessing HSE and PSM elements of CMs that impact Lilly products. - Engaging in developing capabilities with new technologies that may impact portfolio assets. - Adhering to the expectations of the Lilly Red Book in interactions with API EM's CMs. Your key objectives and deliverables include: - Coaching and mentoring Process Team Members. - Utilizing past experiences to provide insight and feedback to the Lilly / CM Joint Process Team (JPT). - Championing the application of statistical thinking for process monitoring and decision-making. - Supporting root cause analysis around incidents. - Identifying process knowledge gaps and enabling the development of key process knowledge. - Providing process and equipment support for production issues. - Supporting continuous improvement activities and cost reduction opportunities. - Reviewing equipment and process system requirements. - Serving as a liaison for HSE and PSM oversight at CM sites. - Ensuring adherence to Lilly policies and procedures. Basic Requirements: - 10 years of work experience in GMP manufacturing/process engineering. - Deep technical knowledge of API / Drug S