Johnson & Johnson jobs in Nashville, TN

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: MedTech Sales Job Sub Function: Technical Sales - MedTech (Commission) Job Category: Professional All Job Posting Locations: Montgomery, Alabama, United States, Nashville, Tennessee, United States Job Description: We are searching for the best talent for Senior Ultrasound Clinical Account Specialist to be in Alabama Region/Nashville, TN. About Cardiovascular Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech The Senior Ultrasound Clinical Account Specialist (ULS CAS) is accountable to provide technical and clinical product support to health care providers including Electrophysiology (EP) physicians, Interventional Cardiologists (IC) and laboratory staff for electrophysiology diagnostic and therapeutic catheters and systems - with an emphasis on the AcuNav and SOUNDSTAR catheters - to enable practitioners to perform advanced cardiac ablation and interventional procedures respectively. The CAS is responsible to build and maintain mutually beneficial relationships with physicians & EP laboratory staff in order to identify and foster interest in new products or product indications to grow and develop the company's product and technology utilization. The ULS CAS directly partners with a Regional Business Director, Territory Managers, EP CAS, Field Service Engineers and Field Management to ensure alignment and coordination of activities to meet business objectives. As the Senior Ultrasound Clinical Account Specialist, you will: * Provide expert clinical product and technical assistance and training to EP/IC physicians and staff on the effective use of AcuNav and SOUNDSTAR catheters in EP and IC procedures. * Provide expert clinical product and technical assistance and training to physicians and EP Lab Staff on the effective use of electrophysiology systems and catheter equipment (e.g., The CARTO System and appropriate software modules including CARTOSOUND , CARTOMERGE and the Stockert RF generator) during case procedures within an assigned geography, and in a manner that leads to meeting and exceeding business goals. * Educate customers on all electrophysiology products to optimize effective usage by providing technical and clinical information and in-service training. Shares best practices to increase value for customers. * Use consultative selling techniques to identify potential sales opportunities within the account. * Create awareness of electrophysiology solutions and facilitates Territory Sales Manager (TM) contact with the key decision makers to drive incremental business. * Maximize customer case support capability through proper planning and scheduling techniques. * Drive collaboration and maintains consistent, open lines of communication across the assigned responsibilities with internal partners including regional teams/Pods (i.e. TMs, EP CAS and other ULS CAS), as well as support personnel (i.e. Marketing, FSE, RBD). * Drive collaboration and maintain consistent, open lines of communication with external partners. * Develop and share best practices with US Field Sales and Service colleagues and internal partners and develop and grow mutually beneficial customer relationships within and beyond the EP/IC lab, including, but not limited to physicians, nurses and technicians, clinical and hospital administrators and staff. * Stay current on company products instructions for use (IFU), best practices and technical troubleshooting, as well as relevant scientific clinical literature and new product information. * Prioritize and appropriately respond to requests in a high stress environment and maintain composure and problem-solving focus during stressful interactions. * Engage in diagnostic dialogue with multiple internal and external business partners and stakeholders, and formulate solutions based on dialogue and input gained during session. * Provide mentoring for new electrophysiology commercial team members as requested. * Perform other duties assigned as needed. Required Qualifications: * A minimum of a bachelor's degree, or 4 years of relevant professional work/military experience * A minimum of 2 years of experience in clinical echocardiography lab * Must have and maintain certification as a Registered Cardiac Sonographer (RCS) or as a Registered Diagnostic Cardiac Sonographer (RDCS) in adult or pediatric echocardiography. * Must have and maintain advanced clinical ultrasound and echocardiography knowledge of technology, advancements and the business landscape. * Maintain clinical knowledge of healthcare industry, disease states, and therapeutic and institutional trends. * A valid driver's license issued in the United States * Will be required to maintain advanced clinical knowledge of cardiac ablation and cardio imaging, technical knowledge of EP technology, advancements, and the business landscape. * Maintain clinical knowledge of healthcare industry, disease states, and therapeutic and institutional trends. * The ability to travel related to this role is required. Must be willing and able to travel up to 40% overnight locally, regionally, and nationally, sometimes on short notice. * Position requires sitting for extended periods of time, working in a hospital laboratory setting, attending live patient cases, and wearing protective gear (i.e. lead aprons), and willing to work variable hours to meet patient needs * May be required to lift up to 60 lbs. Strongly Preferred: * Electrophysiology/Cath Lab or EP/Cardiovascular Device Industry experience. * Maintaining at least one of the following industry certifications - CEPS (IBHRE), RCES/RCIS * Experience working with highly complex technical systems and/or working in a critical patient care setting. * Effective and timely communicator with co-workers and all levels of patient care team. * Self-starter who performs well with autonomy and can be flexible in a dynamic work environment. * Problem solver who can think critically in high pressure environments. * Receptive to constructive feedback and collaborates and works well in team environment. * Able to take large amounts of data and translate information into actionable insights * Hunger for learning and building new skills Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. #RPOAMS

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. Organization Overview: Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing areas at Lilly's new Lebanon, Indiana (LP2) site. The QA Operational Support position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility. As the project progresses, this role will transition to site-based process team supporting one of the following manufacturing areas: * ATMP Gene Therapy Drug Substance Manufacturing * ATMP Gene Therapy Parenteral Manufacturing * QC Laboratory * Packaging * Warehouse Logistics * Facility, Utility and Maintenance Responsibilities: * Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance * Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design * Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase * Actively participate in required design reviews and final design qualification activities * Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures * Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc. * Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas * Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff * Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group * Support the definition and execution of inspection readiness activities including support of site self-inspections in GQA * Lead project initiatives needed in support of the project and Quality function * Resolve or escalate any compliance issues to the project, site, and Quality Management * Provides guidance for deviations, observation handling; change control proposals; document creation and revisions. Basic Requirements: * Bachelor's degree in relevant field (preference for scientific or engineering field) * 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles * Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation Additional Preferences: * Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing * ASQ Certified * Computer System Quality Assurance experience * Previous facility or area start up experience * Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging * Previous experience with lab equipment delivery and qualification * Previous experience with management of utilities, facilities, maintenance, and warehouse logistics * Previous experience with Manufacturing Execution Systems. * Previous use of KNEAT - or other electronic validation software * Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills * Demonstrated strong problem solving and decision making skills * Previous technical writing experience * Technical aptitude and ability to train and mentor others Additional Information: * Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office * Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Organization Overview For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Position Brand Description: The Lead Operator - Fire Officer - Captain HSE - Lebanon is part of the Lilly Health, Safety, and Environmental (HSE) team and has responsibility to lead/coordinate the on-site emergency response team as a shift lead and Incident Commander in the absence of a Chief Officer. This role will be part of the shift staff that supports a 24/7/365 organization working 24 hours on 48 hours off schedule. The position also interacts with the Lilly Medical Director, Employee Health Services (EHS), security, fire safety systems, local building staff/management teams, and outside agencies. This role is responsible for responding to emergency and special events, as well as participating in various site's emergency response programs, fire safety programs, and supporting departmental and site projects, as needed. When not responding to emergencies and special events, this position is responsible for the completion of required maintenance, inspections and training activities. Key Objectives/Deliverables/Responsibilities: * Support and execution of the on-site emergency preparedness and response plan. * Participate in pre-emergency planning and assist in the implementation of the emergency plans with both on-site and local emergency organizations. * Inspect and maintain departmental equipment, supplies, and facilities to ensure response readiness. * Monitor activities to ensure conduct and performance conform to departmental standards. * Respond to all site fire, hazmat, and medical emergencies and assume command in the absence of superior officer. * Participate in the operation of departmental in-service training. * Prepare a variety of reports and records. Minimum Requirements: * Training/certifications: Indiana Firefighter I/II, Emergency Medical Technician (EMT-B or higher), Hazardous Materials Technician, Fire Officer Strategy and Tactics. * CPR Certified * Must hold and maintain a valid driver's license. * Minimum of five (5) years' experience in fire and rescue. Additional Preferences: * Effective interpersonal and relationship management skills. * Effective communication skills, both verbal and written. * Effective time management skills. * Strong relationship building skills internal and external to the company. * Possess basic computer and administrative skills. * Must be able to lead teams and set direction to successfully and safely respond to emergencies. * Experience interfacing with regulatory agencies regarding emergency response. * Experience in a positive safety culture or in helping to improve a safety culture. * Experience in all roles within incident command system. * Training / Certifications (Indiana or National Registry): * Instructor 1 / 2 * Driver Operator / Pumper * Confined Space Technician * Certified CPR Instructor * Emergency Vehicle Operator Certification (EVOC) * NIMS (100, 200, 300, 700, 800) Other Information: * This position supports a 24/7/365 operation with 24-hour shift work, weekends, holiday required once fully operational. * Additional onsite presence may be requested to address testing, consultation or emergency situations. * Minimal travel required. * Response and required fire department trainings as a line officer within the Incident Command System * First responder requiring successful completion of NFPA 1582 or EHS approved physical, quantitative fit test for Self-Contained Breathing Apparatus (SCBA), and Work Performance Evaluation (WPE) 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $25.96 - $38.08 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply. The Operator - Material Handling will be a critical part of Operations to ensure materials for production are in the right place at the right time and be responsible for all inbound and outbound material flows through the facility. As an Operator - Material Handling, you will: * Receive and accurately store manufacturing components from outside vendors and other Lilly sites. * Process material movements in the warehouse inventory system and complete cycle counting. * Prepare materials for production by case-picking and hand-picking materials from storage racks and bins. * Process outbound shipments, including intermediates, finished products, and waste. * Follow and execute policies and procedures impacting warehouse activities. * Follow all cGMP and all other regulatory requirements. * Maintain a safe work environment by: * Following all safety requirements and procedures. * Utilizing proper ergonomic techniques. * Maintaining high housekeeping standards and routinely inspecting areas for health and safety issues. * Assisting with implementation of corrective actions and safety improvement projects. * Maintaining learning plan as 100% current. * Participate in quality initiatives and audits. * Perform other duties as assigned by the supervisors. Basic Requirements: * High-School Diploma or GED Additional Preferences: * Previous warehouse/logistics experience in a cGMP environment. * SAP Experience. * Ability to use Computer tools (desktop, MS Office) and electronic tools (Scan guns and tablets). * Ability to pick-up / move up to 35-pound containers. Other Information: * Certified to operate assigned powered industrial trucks or ability to obtain certification within 3 months of employment start. * During the start-up phase of the project, the schedule will be primarily day shift (8-hour workdays - Monday through Friday). There may be periods of (or a permanent transition to) 10- or 12-hour shifts depending on the needs of the operation (and/or temporary learning assignments to other facilities). * During the start-up phase of the project, the location will be in temporary offices at the Lebanon site for onboarding and training. * Ability to work overtime, weekends, and off shifts as needed. * Tasks may require handling hazardous materials in accordance with safety procedures. 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. 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 35,000 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. Organization Overview: Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Position Brand Description: The Quality Improvement Technician (QIT) will develop and improve the control systems to support the production of API molecules used in Lilly medicines. A successful candidate will interface with the Process Team to allow the teams to measure, evaluate, and improve performance in the areas of Safety, Quality, Throughput, and Cost while upholding a safety-first, quality-always mindset. In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Responsibilities: * Coordinate cleaning, turnaround, and maintenance activities in the production area. * Design and maintain the required turnaround documentation. * Review and monitor relevant Standard Operating Procedures (SOPs) and SOP updates. Execute unplanned SOP changes. * Influence adherence to cycle time. * Coordinate housekeeping and fit and finish programs. * Assist Operations Associate and Operations Associate Director in planning and scheduling daily work. * Support Process Engineers in daily operations. * Ensure requests/concerns from Operators are appropriately logged and follow-up is completed. * Identify and support the implementation of improvements from Operations. * Own the issuance of non-routine work instructions with input from Process Chemists/Process Engineers. * Organize/complete non-routine sample/repackaging. * Generate work orders for corrective maintenance. * Assist in the training of operations personnel. * Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards. * Understand other area processes & their operational hazards and being able to react appropriately. * Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects. * Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification. Basic Requirements: * High School Diploma or equivalent * 3+ years' experience supporting an API or chemical manufacturing operation or equivalent. * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. * Completion of Post Offer Exam or Completion of Work Simulation if applicable. * Ability to effectively communicate (electronically, written and verbal). * Basic computer skills (desktop software) are required. Additional Preferences: * Previous experience in facility/area start-up environments. * Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals. * Solid understanding of FDA guidelines and cGMP requirements. * Strong organizational skills and ability to handle and prioritize multiple requests. * Knowledge of lean manufacturing principles. * Flexibility - ability to troubleshoot and triage challenges. * Ability to understand technical nomenclature and language as well as work with mathematical formulas. * Manual material handling as appropriate. * Bend, reach, stretch, climb ladders, and work in tight spaces. * Stand for long period. Additional Information: The QIT role operates on a work schedule of Monday through Friday, 8 hours per day. The job may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend training activities etc. * Ability to work flexible schedules during startup period. * Ability to work overtime as required. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: 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, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $28.12 - $41.25 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Organization Overview: Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities, including Gene Therapy. Located in Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, and start up the facility for both clinical and commercial supply. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing. Position Description: In addition to new modalities manufacturing, this facility will also provide oversight of external manufacturing of new modalities. The Scientist - Quality Control Project Management - Advanced Therapies is a technical role in the Quality Control Laboratory helping to ensure the manufacture of products to predetermined standards to meet both Lilly and external requirements by focusing on managing the testing of products manufactured and/or tested at locations external to Lilly. This role is responsible for the planning, coordination, and execution of laboratory testing of all methods of products managed by the Lilly Lebanon Advanced Therapies Manufacturing (LP2) team. The successful candidate will work in partnership with internal LP2 personnel for technical support, with the Lilly global Analytical Sciences and Quality Control Organization (AQCO), External Manufacturing teams (API-EM and DP-EM), as well as third-party contract manufacturing and testing partners to ensure that products are tested and controlled as needed to achieve successful product production. Key Objectives/Deliverables: * Serve as a liaison between contract manufacturers and Lilly to perform coordination, review, and interpretation of quality control product testing data and serve as the initial point of contact for all quality control-related issues. * Provide analytical support, project leadership, and/or technical direction for testing performed internally to LP2 or by third-party contract partners. * Oversee and participate in the transfer of analytical methods, including setting strategic direction, authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations. * Leverage organizational understanding to identify correct SMEs to utilize their technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. * Track project progress and performance, including maintenance of transparent and accessible project documentation (timelines, budgets, status), ensuring all team members and partners have access to up-to-date project information. * Define project scope, objectives, and deliverables in collaboration with partners; develop detailed project plans including timelines, milestones, and resource allocation; identify project requirements and ensure alignment with organizational goals. * Provide technical oversight for Periodic Management Reviews. Leads resolution of technical issues including those related to control strategy and manufacturing. * Help develop a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group. * Interact effectively with business partners and auditors to communicate and resolve issues and gain a clear and accurate understanding of each other's requirements. * Network with groups internal and external to Lilly to understand best practices, share knowledge, participate in technical planning, and to ensure customer needs are met. * Help define and execute inspection readiness activities for manufactured products. * Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs. * Build and maintain relationships with development partners and central technical organizations. Minimum Requirements: * Bachelors (4-year) degree in a science field related to chemistry, microbiology, or biology. * 4+ years of demonstrated relevant experience in a GMP manufacturing environment. Additional Preferences: * Demonstrated proficiency in project management, data management practices, and ability to coordinate complex projects. * Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences. * Strong oral and written communication skills and demonstrated through documentation and presentation skills. * Proficiency in delivering complex tasks and/or tasks that are cross-functional. * Experience with large molecule and/or viral vector testing techniques. * Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology. * Demonstrated strong interpersonal interaction skills. * Ability to focus on continuous improvement. * Deep understanding of compliance requirements and regulatory expectations. Additional Information: * May require up to 20% travel, including overseas, requiring a passport. * Role is located in Lebanon, IN and requires on-site attendance within Lilly policy when not traveling for work-related responsibilities. 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility represents Lilly's largest investment in manufacturing capacity and is intended to support current and future products, including new modalities. This is a unique opportunity to be part of the startup team for a greenfield manufacturing site. The successful candidate will help build the processes and facility to enable a successful startup into GMP manufacturing operations. Main Purpose and Objectives of Position: The Lead LDAR (Leak Detection and Repair) Technician is part of the LP1 HSE organization, working closely with the maintenance and operations teams. This role provides technical expertise in the development, implementation, and improvement of the LDAR program. The Lead LDAR Technician ensures that all LDAR systems operate efficiently and comply with regulatory standards to minimize emissions and ensure environmental compliance. This role will be instrumental in developing the LDAR management system and supporting the development of others responsible for maintaining the equipment and processes. Key Responsibilities: * Ensure team members are knowledgeable and compliant with safety procedures, policies, permits, and practices. Support incident investigations and maintain proper housekeeping standards. * Ensure compliance with cGMPs, Global Quality Standards, and local procedures related to LDAR activities. * Support the development and implementation of LDAR programs, procedures, and tools. * Coordinate LDAR activities with production, operations, maintenance, engineering, and vendors. * Maintain accurate records of LDAR activities, including monitoring data, repair logs, and compliance reports. * Conduct regular inspections and audits to ensure adherence to LDAR regulations. * Lead or support initiatives aimed at reducing emissions through process optimization, equipment upgrades, and adoption of best practices. * Serve as a secondary point of contact for regulatory agencies on LDAR-related matters. * Train and mentor operations and maintenance personnel on LDAR systems and procedures. Support onboarding and development of new staff. * Participate in commissioning, qualification, procedure writing, and training related to LDAR systems. * Lead LDAR training to support plant startup and team goals. * Demonstrate flexibility by supporting cross-functional initiatives within Maintenance, Engineering, and Facility teams. Participate in projects and best practice initiatives across departments. Basic Requirements: * High school diploma or equivalent required. Technical certification or associate degree in environmental technology, instrumentation, or a related field preferred. * Minimum of 5 years of experience in pharmaceutical or chemical manufacturing with a focus on environmental compliance and LDAR programs. * Demonstrated knowledge of LDAR regulatory requirements and best practices. * Experience in developing and managing LDAR programs. * Familiarity with EPA and IDEM regulations related to LDAR. Additional Preferences: * BS/MS in environmental engineering, chemical engineering, chemistry, or related field preferred but not required * Experience with environmental monitoring tools and software. * Project management experience. * Ability to lead cross-functional teams and drive continuous improvement. * Demonstrated leadership and communication skills. * Excellent problem-solving and troubleshooting skills. Additional Information: * Tasks may require entering manufacturing areas and wearing appropriate PPE. * May be required to provide support outside of normal working hours including nights, weekends, and holidays. * Travel to other facilities within the Lilly network (Minimal). * As this is a greenfield site, the LDAR program will evolve from development to maintenance. This role may transform as LDAR capabilities mature at the site. 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $28.84 - $42.31 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. 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. Organization Overview: Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Position Brand Description: The Operators for API manufacturing operations are directly responsible for the production of API molecules used in Lilly medicines. Operators will be responsible for upholding a safety-first, quality-always mindset in the production of API while running a production process that incorporates a wide range of unit operations. In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Responsibilities: * Maintain compliance with regulatory requirements at all times. * Support the execution of the production plan for the site. * Carry out daily monitoring testing and cleaning duties as assigned to ensure equipment and systems are in good operating conditions and are maintained in accordance with local and corporate regulatory requirements. * Understand Health, Safety & Environmental (HSE) requirements and the application of Health & Safety/Process Safety standards in order to execute GMP duties. * Understand other area processes & their operational hazards and being able to react appropriately. * Monitor and collect data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems. * Work with Maintenance and Technical Support to respond appropriately to potential production upsets or equipment failure. * Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing. * Communicate with other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover. * Participate in daily shift huddles / meetings to both understand and set expectations for daily operational goals. * Actively participate in assigned building & area operations such as safety audits, procedure co-ordination, housekeeping and improvement projects. * Be trained and qualified on all specified unit operations within the building. * Identify concerns for informal or formal discussion (shift meetings, safety representative). * Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification. * Must be able to use specified company supplied personal protective equipment (PPE) (e.g. hair & beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) for long periods of time. Basic Requirements: * High School Diploma or equivalent * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. * Completion of Post Offer Exam or Completion of Work Simulation if applicable. Additional Preferences: * Previous experience in facility/area start-up environments. * Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals. * Solid understanding of FDA guidelines and cGMP requirements. * Strong organizational skills and ability to handle and prioritize multiple requests. * Knowledge of lean manufacturing principles. * Flexibility - ability to troubleshoot and triage challenges * Ability to understand technical nomenclature and language as well as work with mathematical formulas. * Emergency Response Experience * Industrial, military, volunteer, career firefighter * Indiana State or IFSAC Certification - Fire 1, Hazmat Technician * Ability to effectively communicate (electronically, written and verbal). * Basic computer skills (desktop software) are required. * Manual material handling as appropriate. * Bend, reach, stretch, climb ladders, and work in tight spaces. * Stand for long periods as needed Additional Information: * Ability to work 12-hour rotating shifts. * Ability to work flexible schedules during startup period. * Ability to work overtime as required. * Depending on the candidate's experience, the position may require a short-term assignment of 1-6 months domestically or internationally to train and be certified on existing processes and establish contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: 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, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. 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 35,000 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. Organization Overview: Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Position Brand Description: The Health Safety and Environment (HSE) Permit Writer will develop and maintain safe work permits within the production building. A successful candidate will interface with the Process Team and Project Team to manage equipment availability. In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Responsibilities: * Safe work permit preparation including the coordination of operations, project, and maintenance personnel. * Execute the required safe work permits, which includes but is not limited to lock out tag out (LOTO), hot work, confined space entry, etc. * Develop and maintain equipment specific instructions including but not limited to lock-out, tag-out. * Develop and maintain confined space entry risk assessments. * Develop and maintain permitting equipment and supplies. * Perform safety audits and maintain an audit ready status. * Review and monitor relevant Standard Operating Procedures (SOPs) and SOP updates. Execute unplanned SOP changes. * Influence adherence to project and maintenance schedules. * Support Process Engineers/Maintenance/Projects and Supervision in daily operations. * Identify and support the implementation of improvements from Operations. * Ownership of daily tasks, preventative maintenance or breakdowns. * Conduct continuous improvement projects which are aligned with safety and quality expectations and meet operational needs * Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards. * Understand other area processes & their operational hazards and being able to react appropriately. * Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects. * Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification. Basic Requirements: * High School Diploma or equivalent * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. * Completion of Post Offer Exam or Completion of Work Simulation if applicable. * Ability to effectively communicate (electronically, written and verbal). * Basic computer skills (desktop software) are required. Additional Preferences: * Previous experience in facility/area start-up environments. * Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals. * Solid understanding of FDA guidelines and cGMP requirements. * Strong organizational skills and ability to handle and prioritize multiple requests. * Knowledge of lean manufacturing principles. * Flexibility - ability to troubleshoot and triage challenges. * Ability to understand technical nomenclature and language as well as work with mathematical formulas. * Manual material handling as appropriate. * Bend, reach, stretch, climb ladders, and work in tight spaces. * Stand for long period. Additional Information: The Safety Permit Writer role operates on a work schedule of Monday through Friday, 8 hours per day. The job may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend training activities etc. * Ability to work flexible schedules during startup period. * Ability to work overtime as required. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: 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, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $28.84 - $42.31 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. Position Overview The Sr. Director - QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel. Additionally, the Sr. Director - QA is responsible for maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements. Key Responsibilities * Serve as Site Quality Leader on the Lilly Site Lead Team. * Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments. * Lead the API Quality Team and manage its agenda. * Support quality forums (e.g., Deviation and Change Control Boards). * Develop and monitor a site Quality Plan and metrics. * Coordinate and manage regulatory inspections. * Review and approve manufacturing and quality system documents. * Ensure adequate QA staffing and provide coaching and development. * Use HR tools for performance management, staffing, and succession planning. * Contribute to QA business planning and site-wide strategic planning. Basic Requirements * Bachelor's degree (STEM degree preferred) * 10+ years of pharmaceutical manufacturing quality experience * 5+ years of supervision/leadership experience Additional Preferences * Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs * Proficient in statistical analysis and computer applications * Strong interpersonal, communication, and networking skills * Ability to influence diverse teams and manage multiple priorities * Demonstrated problem-solving and analytical thinking 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Lilly IT builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Lilly IT is that we create new possibilities through tech to advance our purpose - creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of our business. Research IT unites science with technology to accelerate the Research and Development of medicines and to deliver therapeutic innovations. The team leverages technology and platforms to streamline scientific experimentation to help Researchers follow the science, to understand the disease and identify potential therapies. They are at the forefront of advanced analytics to enable data driven drug discovery; to innovate so Scientists can rapidly analyze and accelerate the discovery of new medicines. What You Will Do: * Closely listen, interpret, and understand customer needs into technical terms to solution and action * Coordinate with other Lilly groups and vendors regarding requirements, operating system requirements, additional hardware requirements and costs * Create strategy and plan to provide qualified infrastructure platforms and be able to execute the defined plan. * Troubleshooting problems on platforms including Citrix, RealVNC, VDI, Linux, Windows OS, iGel technology and other workstation connected hardware as well as Telecom. * Experience in configuring DNS, NTP, Proxy, etc, for specialized Manufacturing and Lab workstations. * Provide strategy for immediate and future upgrades/patching of hardware and software applications. * Providing supporting documentation for validation and testing of upgrades * Drive the validation of new and existing systems by providing technical design information to assure GMP data integrity Your Minimum Requirements: * Bachelor's degree in computer science, Information Technology or related technical field * Minimum 4+ years in a technical or operational IT role, with experience supporting end-user workspaces, hardware (e.g., scanners, printers), networking systems, and/or telecom technologies * Minimum 3+ years of experience in Manufacturing or Clinical development facilities. * Minimum of 3+ years work experience in pharma, GMP, FDA or other highly regulated environments * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. What You Should Bring: * GMP Knowledge * Advanced knowledge of network technologies * Experience troubleshooting network connected devices in a complex segmented lab and manufacturing network environment Other: * This is a hybrid position located at Lilly Technical Center -N until the completion of the Lebanon Medicine Foundry 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $151,800 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future. The Senior Principal Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer as a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Key Objectives/Deliverables: * Technical Leadership * Mentor process control team, including design, controls philosophy, implementation and commissioning * Process control work implementation and coordination * Develop and implement the Automation Engineering Project Plan. Operational Excellence * Technically lead and oversee the work of Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications. * Lead/Participate in design reviews and DeltaV application software reviews, attend equipment and software FATs * Lead a team of automation engineers supporting commissioning * Provide periodic status updates to Project Management * Devising functional requirements and process control strategies for control systems in collaboration with Process Engineering * DCS and SCADA software design, coding/configuration and testing (sequence logic, graphics, batch software etc.) * Perform automation engineering activities including design, tuning and troubleshooting of control loops * Implement and support electronic systems (such as plant historians, applications and software integration) used to capture process automation related production data * Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation * Automation support for capital projects including new product introductions * Promoting the use of automation to improve productivity, operational efficiency and compliance * Developing a 'network' of corporate contacts and leveraging corporate expertise when needed Organizational Capability * In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. * Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. * Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement * Demonstrated ability to influence peers and business partners * Good written and verbal communication skills for both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: * Minimum B.S. in Engineering and experience in Automation Engineering, preferably in Biologics manufacturing. * 8+ years working experience in Biopharma engineering, operations, or manufacturing. * Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, PLC and MES systems (DeltaV, Rockwell, Syncade, etc). * Experience in facilitating and driving decision-making at an organizational level. 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Overview: Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. Main Purpose and Objectives: Lilly is seeking a process chemist to join its Lebanon API TS/MS (Technical Services/Manufacturing Science) team. This position is responsible for designing and executing lab experimentation aimed to transfer processes, characterize processes, troubleshoot process upsets, and provide recommendations for process improvements. The TS/MS Process Scientist is part of the Lilly Lebanon API TS/MS laboratory team. This position will be small molecule focused and will require interaction with Quality Assurance, Quality Control, Procurement, Warehouse, Regulatory departments, and other Lilly sites. Knowledge of chemistry and understand the scientific principles required for the manufacturing and testing of intermediates and bulk drug substances is required. Knowledge of organic synthesis and experience in API manufacturing are a plus. Knowledge of peptide synthesis is a plus. Key Responsibilities: * Complete laboratory experimentation aimed at achieving the successful process development and transfer * Developing experimental studies to address process upsets in routine manufacturing * Design and perform range finding studies to enable effective process characterization * Identify potential for process optimization to improve yield and throughput * Coordinate with TS/MS team to setup models to support manufacturing as required. * Accurately record data in accordance with TS/MS laboratory procedures * Adhere to all Environmental, Health, and Safety standards. * Effective management of multiple projects. * Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. * Communicate effectively in both written and oral formats. * Participate in internal/external audits as needed. Basic Requirements: * Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmaceutical Science). Advanced degree (MS or PhD) preferred but not required. * 1+ year of laboratory experience in a cGMP environment. Additional Preferences: * Excellent communication skills, both oral and written. * Ability to independently master assigned processes and to coordinate activities with internal and external partners. * Advanced degree in Organic Chemistry * Experience with small molecule pharmaceutical development and characterization. * Experience in API manufacturing. * An understanding of cGMP and regulatory requirements. * Experience with continuous processing is a plus * Experience with process characterization is a plus * Experience transferring processes into GMP manufacturing is a plus * Experience with chemical process safety/calorimetry is a plus 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Tank Farm & Solvent Recovery (TFSR) Engineering Manager 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 35,000 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 it back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We are looking for people who are determined to make life better for people around the world. Lilly is currently constructing an advanced manufacturing facility for production of API (active pharmaceutical ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. The TFSR Engineering Manager is responsible for managing the technical and administrative leadership of TFSR engineers at the Lebanon Plant API manufacturing site. The role is responsible for maintaining the site's tank farm and solvent recovery infrastructure and systems to a state of compliance. It must ensure that infrastructure is fit for use when needed, maintenance and reliability techniques are efficient and effective, and appropriate corrective and improvement actions are taken when necessary. In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), leadership roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Key Responsibilities: TFSR Engineering: * Build deep technical engineering expertise and capability over the following areas: * Tank Farm, to include bulk loading/unloading of both trucks and rail, bulk solvent/material handling, storage & distribution, and liquid waste collection & management. * Solvent recovery and waste systems. * Support systems, including bulk nitrogen, ventilation, and cryogenic emission systems. * Responsible for all systems under their responsibility (GMP And Non-GMP Systems and ancillary systems) and understanding their applications in pharmaceutical manufacturing, trending critical process parameters and awareness of industry standards and trends. * Ensure compliance related activities such as deviations, change controls and CAPA's are resolved and implemented in conjunction with other teams. * Ensure the assigned systems and processes are aligned with external regulations and industry / Lilly standards and best practices. * Lead and participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals. People Management: * Lead and manage resources effectively * Ensure team is compliant & trained on programs, procedures, policies, etc. And oversee team's learning plans * Lead safety communications with staff and participate in safety audits * Lead the performance management initiatives for team * Support and drive development plans and career path development for employees * Ensure team is aligned and working towards goals & objectives (site and team) * Provide technical guidance, management, mentoring and development of engineers. * Set expectations for a positive & proactive safety culture. Engineering Management: * Provide engineering direction for projects & design needs * Engage in regulatory and internal audit support * Own incident reporting, investigating, and corrective measures * Operate in a continuous state of compliance, as well as look to become more effective and efficient with our processes * Follow and ensure compliance of standards (quality, global engineering, etc.) * Establish and maintain metrics, as appropriate to support manufacturing * Develop local processes and procedures in accordance with the fume system * Provide guidance in developing scope for projects, as well as time schedules and cost estimates. * Ensure successful completion of documentation for technical changes and projects under their management, including hse documentation. * Support safety and environmental process activities and be a role model for leadership in these areas. * Direct and develop engineers in capital project execution including process design, equipment specification, operator training, start-up support, and troubleshooting. Basic Requirements: * Bachelor's degree in engineering or related field * 5+ years extensive progressive chemical process and plant experience is necessary for this position * 2+ years supervisory experience in engineering. Additional Preferences: * Experience in facility/area start-up environments * Demonstrated leadership experience in manufacturing or maintenance. * Ability to collaborate with a team, make independent decisions, and influence diverse groups. * Good analytical/critical thinking. Excellent interpersonal skills. * Ability to effectively communicate both written and verbally at all levels. * Ability to prioritize, set objectives and meet targets. Ability to provide high level customer service. 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $99,000 - $145,200 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Job Summary As a TSMS Lab Advisor at Eli Lilly and Company, you will be a key contributor to our Technical Services and Manufacturing Science (TSMS) team, providing expert scientific and technical guidance within our laboratory operations. You will ensure the highest standards of quality, compliance, and scientific rigor are maintained in support of our pharmaceutical manufacturing processes. Job Responsibilities * Develop laboratory process and analytical expertise, provide technical oversight and stewardship for small molecule and peptide manufacturing * Design, oversee, and perform complex laboratory experiments, data analysis, and interpretation to support process development, characterization, and optimization. * Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and research and development teams to resolve technical challenges and drive continuous improvement. * Provide scientific and technical leadership for troubleshooting activities related to manufacturing deviations and out-of-specification results. * Active role in mentoring and developing fellow TSMS laboratory scientists to facilitate tech transfer * Ensure compliance with all relevant internal procedures, external regulations (e.g., cGMP, FDA, ICH), and safety guidelines. * Stay abreast of industry trends, new technologies, and scientific advancements in pharmaceutical analysis and manufacturing. Minimum Qualifications * Education: Master's, or Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline. * Master's degree with 5+ years of relevant experience in a pharmaceutical or biotechnology laboratory setting OR Ph.D. with 2+ years of relevant experience in a pharmaceutical or biotechnology laboratory setting. * Expertise in small-scale peptide and/or small molecule process development and scale-up * Extensive hands-on experience with advanced analytical techniques such as HPLC, GC, LC-MS, GC-MS, spectroscopy (UV-Vis, FTIR), and dissolution testing. * Strong understanding of cGMP regulations, ICH guidelines, and pharmacopeial requirements (USP, EP, JP). Additional Preferences * Proficiency in method development, validation, and transfer. * Experience with laboratory information management systems (LIMS) and chromatography data systems (CDS). * Excellent problem-solving, critical thinking, and data analysis skills. * Strong written and verbal communication skills, with the ability to effectively present complex technical information. * Demonstrated ability to work independently and as part of a cross-functional team. * Proven leadership abilities and experience mentoring junior staff. 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $209,000 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Sr. Engineer - Validation Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will participate in the design, commissioning and start up the facility for both clinical and commercial supply. We are seeking a Validation Engineer at Lebanon Advance Therapies Manufacturing in Lebanon, IN. Validation engineer will be responsible for the following: * Equipment/System Validation * Life Cycle Asset Management * Requalification Activities * Temperature Mapping * Asset Induction * Cleaning / Sterilization (Parts Washer, Autoclave) * Support Process and Computer Qualification Activities * Lead validation / qualification protocols per continued process verification, risk impact assessments, and support commissioning Core Responsibilities Facility Start-up: * Apply thorough understanding of regulatory requirements, relevant SOP curriculum, routine project procedures, project management, and other training to support manufacturing and engineering in projects such as cleaning, sterilization, equipment and utilities commissioning and qualification * Assess, qualify, and validate equipment, critical systems (utilities), facilities, computer system, cleaning and steaming processes, manufacturing, and equipment processes, as applicable * Participate and interface with cross-functional project team and represent validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: design qualification, FAT/SAT, commissioning, engineering, and process validation * Provide a positive and equitable working environment emphasizing the Lilly's Values: Integrity, Excellence, and Respect for People * Provide validation engineering support to site with a strong focus on right first time and on schedule facility start-up (e.g. design reviews, process safety assessments, User Requirements, C&Q support, unit operation shakedown and startup, facility operational readiness) * Represent validation during tech transfer activities identifying current and anticipated requirements for cleaning efforts as required. Lead technical projects as they pertain to cleaning and cleaning validation. Provide technical input to strategy/philosophy for cleaning validation and engineering changes. * Support the IQ, OQ, and PQ strategy, design, and execution for LP2 systems and equipment * Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards, Lilly procedures, and regulatory requirements Facility Operations: * Develop and maintain the basis of safety for equipment as required * Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team * Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control * Monitor, assess and document equipment performance to maintain ongoing qualification * Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions Basic Qualifications * Bachelor's Degree in Chemical, Process, or Mechanical Engineering * Experience in cleaning process, process equipment, facilities and GMP critical support systems * Minimum of three (3) years of relevant experience in regulatory, quality, validation, and /or manufacturing operations Additional Skills/Preferences * Deep technical interest and understanding in the field of Chemical Engineering * Strong analytical and problem-solving skills * Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals * Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented * Guidance/mentoring of others through processes * Flexibility to meet business needs * KNEAT Experience 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. The Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future. The Engineer is a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. The engineer will provide Automation, Process Controls and Data Historian expertise and support historian systems operating areas across site. The Engineer will also function as the main Data Architect to ensure proper data contextualization and democratization of operational data for compliance and data analytics. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Key Objectives/Deliverables: * Technical Expertise * Mentor process control team, including design, controls philosophy, implementation and commissioning * Process control work implementation and coordination * Develop and implement the Automation Engineering Project Plan. Operational Excellence * Technically collaborate with Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications to ensure Data historization and architecture is considered. * Provide periodic status updates to Project Management * Work with Engineering, Operations and many cross functional groups to trouble shoot issues, making changes to the site data historian system (OSI PI) in line with site change control procedures and site standards, responding to system events and performing routine system maintenance checks * Maintain Data Historian System health and respond to issues as they arise * Develop standard operating procedures, work instructions and other job aids to ensure the appropriate level of documentation is in place to train on, maintain and operate OSI PI, alarm management and alarm notification systems. * Provide subject matter expertise on data historian systems design, development, installation, testing, validation, and lifecycle support. * Ensure solutions are delivered by system Integrators, equipment vendors and others that can be integrated to the site data historian per the site standards and data management strategies. This includes developing requirements for the system in line with industry and Lilly standards. * Design, configuration, and testing of the platform (OSI PI). This includes: * OSI PI Server Infrastructure * OSI PI Integration with Emerson DeltaV DCS solution * OSI PI Interfaces with other systems (e.g. BMS, PLCs, Remote IO) * OSI PI Asset Frame design and build * Other OSI PI related solutions such as PI Vision * Implement and support electronic systems (such as plant historians) used to capture process automation related production data * Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation * Automation support for capital projects including new product introductions * Promote the use of automation to improve productivity, operational efficiency and compliance * Developing a 'network' of corporate contacts and leveraging corporate expertise when needed Organizational Capability * In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. * Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. * Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement * Demonstrated ability to influence peers and business partners * Good written and verbal communication skills for both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: * Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major pharmaceutical manufacturing. * 5+ years working experience in Biopharma engineering, operations, or manufacturing. * Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS and MES systems (DeltaV, Rockwell, Syncade, etc). * Experience with: * OSI PI and related applications * Cybersecurity and IOT considerations when managing systems * Awareness of integrating other process automation systems such as DeltaV, BMS, PLC/HMI and similar control systems in a manufacturing environment * Industrial communication protocols such as BACnet/IP, modbus, HART, OPC DA & UA, Profibus, Ethernet/IP, RIO * Systems performing backup and restore, disaster recovery * Experience of developing documents with electronic document management system (Kneat, Valgenesis, ALM) * Configuration and support of alarm management systems such as LogMate, Win911 * Experience with Root Cause Analysis methodologies 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. This is an opportunity you don't want to miss! Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over half million to create a new state-of-the-art manufacturing site, in Lebanon, Indianapolis. The brand-new facility will utilize the latest technology for Gene Therapy Manufacturing. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly LP2 Lebanon site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. What You'll Be Doing The Manufacturing & Quality (MQ) IT Associate Director-IT for LP2 will serve as the leader for the IT function for LP2 Site. This role will have a dual reporting line to both the M&Q IT Associated VP and the LP2 Site Head. This role will work hand by hand with the LP2 project lead. Key Objectives/Deliverables: * Ensure site operational readiness from IT perspective. Site start up and integration of IT systems including: * Infrastructure * Enterprise Resource Planning * Warehouse management & logistics coordination * Manufacturing Execution System * Data historian, Real Time Floor Tracking * Data Integration * Data Analytics * Data Integrity * Laboratory information managements * CAPA systems * Access Security * Building Monitoring * Risk Management * MES (Manufacturing Execution System) * Member of the Site Leadership Team and provide IT site functional leadership. * Develop and implement site IT strategic and business plan. * Benchmark on innovative solutions (external and internal to Lilly) * Dynamically adapt road map to site evolution/strategic directions, and new trends/issues. * Partner cross functionally locally and globally to establish and implement site IT roadmap. * Responsible for maintaining a safe work environment. * People * Ensure staffing to meet the site and functional agenda. * Lead, coach, and develop members of the team. * Establish a strong site culture based in Lilly values, expectations, and operational excellence standards. * Support diversity, equity and inclusion in recruiting and development of team members * Lead recognition, pay and promotion decisions. * Lead talent assessment and succession planning activities * Support site recruiting building IT capability. * Compliance * Provide leadership in the development and execution of cGMP and/or improvement plans within the IT function and in support of site cGMP improvement plans. * Define and execute IT inspection readiness activities. * Operational Excellence * Ensure IT organization is functionally strong and operationally focus. * Ensure solution focused organization. * Provide prioritization and barrier removal. * Provide oversight of technical activities within the group * Effectively encourage knowledge sharing and education Your Basic Qualifications (with no sponsorship) * Bachelor's Degree in IT, Engineering, or related technical field. * 7+ years IT Technical Leadership experience working in Pharma and Manufacturing and Quality. * 7+ years of strong experience with MES system implementations, Data Integration and Advance Analytics. Other Information: * Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. * Position will be based out of Lebanon Indiana. About the Organization Lilly IT builds and maintains capabilities using innovative technologies like most prominent tech companies. What differentiates Lilly IT is that we create new possibilities through tech to advance our purpose - creating medicines that make life better for people around the world, like data driven drug discovery and connected clinicals. We hire the best technology professionals from a variety of backgrounds so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of our business. 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $132,000 - $193,600 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. * Responsibilities The Senior Principal Process Engineer provides technical leadership and expertise for production operations in the areas of: coaching and mentoring front line process engineers, developing and sustaining process knowledge, process and equipment support, process optimization, equipment qualification, equipment capability and asset management, and engineering business systems. This role will support production operation in small molecule or peptides manufacturing. Key Deliverables: * Coach and mentor front line process engineers in all aspects of fundamental engineering activities for batch API supply or continuous platforms. * Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles. * Support and peer review root cause analysis for equipment and operational events and other technical documents. * Identify process knowledge gaps that impact equipment and process capability. * Develop or support the capture of key process knowledge (material and energy balances, kinetics, chemistry, equipment design basis, etc). * Support, develop and maintain the basis of safety for process equipment. * Provide engineering support for Process Safety Management (PSM) and Process Hazard Reviews (PHRs). * Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose. * Ensure that changes, maintenance and other interventions do not adversely impact the qualification state of the equipment. * Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control. * Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team. * Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms. * Provide technical oversight of ongoing equipment qualification requirements. * Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose. * Provide guidance in development of test plans for Verification packages and associated critical components. * Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance. Basic Qualifications * Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline * 5+ years of experience in API Manufacturing Unit Operations Additional Skills/Preferences * Deep technical interest and understanding in the field of Chemical Engineering. * Strong analytical and problem-solving skills. * Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals. * Ability to coach others for development of technical knowledge and skills. * Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented. * Guidance/mentoring of others through processes. * Flexibility to meet business needs. Additional Information: * Please note that the role may begin remotely with occasional business travel to the Global Headquarters in Indianapolis, Indiana and to the new site area. Full relocation to the area of new site will be required. Additional information will be provided during the interview process. * Potential for travel (less than 20% - could be domestic and/or international) 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), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $94,600 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly