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Principal Process Engineer
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BioSpace 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 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 put people first and are looking for people who are determined to make life better for people around the world. Overview
Join us in a dynamic role where you will be a pivotal force in our Device and Packaging Manufacturing division, supporting the mission to deliver life-saving medications to patients worldwide. As a Principal Engineer, you will provide technical oversight and work on the development and optimization of automated assembly processes. You will be accountable for technical aspects of quality direct impact systems and critical components used in production, testing, packaging, labeling, and storing of manufactured products to maintain reliable supply for products across the site. Key Objectives And Deliverables
Technical Subject Matter Expert (SME) Oversight
Demonstrate strong ownership for the equipment and packaging area you support by being flexible, proactive and involved. Serve as a responsible engineer for site process lines with deep knowledge of equipment and unit operation design characteristics and capabilities on assembly and packaging lines. Ensure the equipment is maintained in its validated state (AQM). Approve the scope of qualifications and re-qualification monitoring activities. Review and/or approve significant changes, maintenance, and other interventions for potential adverse impact on safety or quality integrity of the equipment or process. Innovation And Problem-Solving
Provide equipment and processing support for production issue resolution and investigation with data analysis and first principles applications, ensuring reliable solutions, safe execution, and regulatory compliance. Identify and drive improvement opportunities. Support complex site investigations of key safety and production issues and events and work on CAPA plans to address such events and prevent recurrence. Regulatory Compliance
Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. Process Optimization
Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success. Use first principles and theoretical knowledge to define scientific approaches to support technical improvements. Utilize understanding of materials, process, and equipment to improve process robustness, reduce variability, and improve operational uptime and effectiveness. Cross Functional Collaboration
Foster knowledge sharing and education within the team and with key internal and external partners to drive alignment and meet manufacturing goals. Collaboratively integrate different disciplines such as quality, technical services, and operations on projects and process performance improvements. Mentorship
Mentor and coach to develop other technical resources on scientific approach, technology, and business behaviors. This may include coaching on first principles, deviation management and processing issue resolution. Create a safe environment for colleagues to share ideas and contribute. Willingness to openly share, speak up, and ensure others understand risks when making business decisions. Safety And Quality Culture
Lead by example in building a culture of safety and quality. Author, review and/or approve GMP documentation including procedures, deviation investigations, technical reports, design reviews, change controls, validation protocols and summary reports. Minimum Qualifications
Bachelor's Degree in Engineering, Science or related field. 5+ years' experience in pharmaceutical manufacturing or regulated industry. In-depth knowledge of GMPs, risk management, and process/equipment commissioning and qualification practices. Additional Preferences And Information
Prior experience in packaging and/or dry/wet device assembling operations. Experience with asset design, delivery, and start up preferred. Safety equipment (PPE) and precautions required in the manufacturing plant environment. Strong technical leadership and communication skills, with ability to influence across disciplines. Strong interpersonal and presentation skills for collaboration across diverse teams. Ability to work well independently and in teams; provide partnership across multiple disciplines. Strong analytical and problem-solving abilities. Variable travel of 0-50% based on site and functional requirements. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly is an EEO Employer and does not discriminate on protected characteristics. Our ERGs offer support networks for members. Actual compensation will depend on candidate’s education, experience, skills, and location. The anticipated wage for this position is $64,500 - $167,200. Full-time employees are eligible for a company bonus and comprehensive benefits. #WeAreLilly
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Principal Process Engineer
role at
BioSpace 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 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 put people first and are looking for people who are determined to make life better for people around the world. Overview
Join us in a dynamic role where you will be a pivotal force in our Device and Packaging Manufacturing division, supporting the mission to deliver life-saving medications to patients worldwide. As a Principal Engineer, you will provide technical oversight and work on the development and optimization of automated assembly processes. You will be accountable for technical aspects of quality direct impact systems and critical components used in production, testing, packaging, labeling, and storing of manufactured products to maintain reliable supply for products across the site. Key Objectives And Deliverables
Technical Subject Matter Expert (SME) Oversight
Demonstrate strong ownership for the equipment and packaging area you support by being flexible, proactive and involved. Serve as a responsible engineer for site process lines with deep knowledge of equipment and unit operation design characteristics and capabilities on assembly and packaging lines. Ensure the equipment is maintained in its validated state (AQM). Approve the scope of qualifications and re-qualification monitoring activities. Review and/or approve significant changes, maintenance, and other interventions for potential adverse impact on safety or quality integrity of the equipment or process. Innovation And Problem-Solving
Provide equipment and processing support for production issue resolution and investigation with data analysis and first principles applications, ensuring reliable solutions, safe execution, and regulatory compliance. Identify and drive improvement opportunities. Support complex site investigations of key safety and production issues and events and work on CAPA plans to address such events and prevent recurrence. Regulatory Compliance
Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. Process Optimization
Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success. Use first principles and theoretical knowledge to define scientific approaches to support technical improvements. Utilize understanding of materials, process, and equipment to improve process robustness, reduce variability, and improve operational uptime and effectiveness. Cross Functional Collaboration
Foster knowledge sharing and education within the team and with key internal and external partners to drive alignment and meet manufacturing goals. Collaboratively integrate different disciplines such as quality, technical services, and operations on projects and process performance improvements. Mentorship
Mentor and coach to develop other technical resources on scientific approach, technology, and business behaviors. This may include coaching on first principles, deviation management and processing issue resolution. Create a safe environment for colleagues to share ideas and contribute. Willingness to openly share, speak up, and ensure others understand risks when making business decisions. Safety And Quality Culture
Lead by example in building a culture of safety and quality. Author, review and/or approve GMP documentation including procedures, deviation investigations, technical reports, design reviews, change controls, validation protocols and summary reports. Minimum Qualifications
Bachelor's Degree in Engineering, Science or related field. 5+ years' experience in pharmaceutical manufacturing or regulated industry. In-depth knowledge of GMPs, risk management, and process/equipment commissioning and qualification practices. Additional Preferences And Information
Prior experience in packaging and/or dry/wet device assembling operations. Experience with asset design, delivery, and start up preferred. Safety equipment (PPE) and precautions required in the manufacturing plant environment. Strong technical leadership and communication skills, with ability to influence across disciplines. Strong interpersonal and presentation skills for collaboration across diverse teams. Ability to work well independently and in teams; provide partnership across multiple disciplines. Strong analytical and problem-solving abilities. Variable travel of 0-50% based on site and functional requirements. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly is an EEO Employer and does not discriminate on protected characteristics. Our ERGs offer support networks for members. Actual compensation will depend on candidate’s education, experience, skills, and location. The anticipated wage for this position is $64,500 - $167,200. Full-time employees are eligible for a company bonus and comprehensive benefits. #WeAreLilly
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