Abbott jobs in Nashville, TN

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

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with a high employer contribution + Tuition reimbursement, the Freedom 2 Save (******************************************************************************************************* student debt program, and FreeU (*************************************************************************************************************** education benefit - an affordable and convenient path to getting a bachelor's degree. + A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity** In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. **What You'll Work On** Working under general direction, provides advanced engineering, sales, educational and technical support in response to complex field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Technical proficiencies and performance are at the experienced level of all Clinical Specialists in the region. + Acts as a senior clinical interface between the medical community and the business. + Demonstrates ability to build and sustain credible business relationships with customers and shares product expertise accordingly. + Identifies reports and advises of customer needs, product performance and potential sales opportunities to sales representatives / directors and/or management to influence sales growth and service of accounts. + Provides engineering, sales, education and clinical support in response to the most complex field inquiries on as-needed basis. Demonstrates a thorough command of all EP products, related product and technical knowledge, trends and players. + Develops, leads and/or facilitates trainings and other programs on EP products to healthcare professionals. + Provides insight, guidance, and feedback to management on market feedback and components of next generation of products. + Provides regional EP procedural case coverage. + Provides additional back-up support to EP Sales Representatives in the following areas: + Sales support; + Regional training seminars; + Clinical studies/data collection; + Trouble Shooting; and, + New product in-service training to physicians, nurses and sales representatives. + Mentors and provides leadership for less experienced Clinical Specialists. + Continuously develops engineering, sales and technical skills relative to the overall Arrhythmia Management strategy, including learning opportunities via Sr. Sales personnel and management. + Assists Training and Education departments with advanced educational seminars, and the preparation of educational materials. + Assists Sales with advanced product demonstrations to visiting physicians and sales personnel. + Remains current on developments in field(s) of expertise, regulatory requirements, and a good working knowledge of company and competitor products, markets, and objectives as well as industry trends. + Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. + Performs related functions and responsibilities, on occasion, as assigned. **Required Qualifications** + Requires a minimum of 1 year in previous position. + Minimum of 3 years of clinical experience (internal or external). + Prior industry/competitive experience (if external). + Solely dedicated to EP support. + IBHRE EP certified. + Considered top performer amongst peers. + Ability to perform complex cases in EP solo. + Ability to mentor and train EP CS roles and CA CS roles on complex mapping cases. + Ability to conduct complex customer education events solo to sell the value proposition of the full EP portfolio. + Performs in top 1/2 of number of cases completed across clinical group at time of promotion in defined Region/Area. + Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s). Apply Now (****************************** **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ********************** (http://**********************/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ************** , on Facebook at *********************** , and on Twitter @AbbottNews. The base pay for this position is $75,300.00 - $150,700.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call ************ or email ******************

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. 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 Lead Operator for API manufacturing operations is directly responsible for the production of API molecules used in Lilly medicines. The Lead Operator 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 all 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 on the above listed systems to ensure equipment and systems are in good operating conditions and they are maintained in accordance with local and corporate regulatory requirements. * Enter Trackwise events, participate in and lead CAPA investigations * Troubleshoot and diagnose process problems and take appropriate actions to minimize deviations or site impact * Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards in order to execute key/critical 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 utility supply upsets or equipment failure. * Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing. * Communicate to other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover. * 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. 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. * Minimum 3 years previous experience in operations Additional Preferences: * Previous experience in facility/area start-up environments * Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals * Ability to assume leadership and prioritize daily priorities without direct supervision * 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 periods Additional Information: * Ability to work rotating 12-hour day or night shifts * 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 $25.60 - $37.55 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. 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 Eli Lilly and Company is seeking a highly experienced and innovative Senior Principal Analytical Scientist to lead critical analytical development and support activities within our Technical Services and Manufacturing Sciences (TSMS) Lab. This role will be instrumental in advancing Eli Lilly's pipeline by providing expert analytical oversight, troubleshooting complex issues, and driving the implementation of cutting-edge analytical technologies to ensure product quality and process understanding. Job Responsibilities * Serve as a subject matter expert in analytical science, providing strategic direction and technical leadership for complex analytical projects within the TSMS Lab. * Lead the design and development of complex LC-MS methods for the identification, quantification, and characterization of small molecules and peptides in support of API commercial manufacturing. * Independently leading deviation investigations and process optimization initiatives using analytical methodologies, especially LC/MS * Proactively identify, evaluate, and implement new analytical technologies and instrumentation to enhance capabilities, improve efficiency, and support API manufacturing * Ensure all analytical activities are conducted in accordance with cGMP, ICH, and other relevant regulatory guidelines. * Collaborate effectively with cross-functional teams including process development, manufacturing, quality control, and regulatory affairs. Mentor and provide technical guidance to junior scientists and laboratory personnel. * Critically analyze and interpret complex analytical data, generating comprehensive reports and presentations to communicate findings and recommendations to stakeholders. * Maintain meticulous laboratory notebooks, author analytical method documentation, and technical transfer documents. Minimum Qualifications * Education: Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline with at least 10 years of relevant experience in the pharmaceutical or biotechnology industry; OR a Master's degree with at least 12 years of relevant experience; OR a Bachelor's degree with at least 15 years of relevant experience. * Technical Expertise: Extensive hands-on experience and deep theoretical understanding of a broad range of analytical techniques, including chromatography (HPLC, GC, UPLC), mass spectrometry (LC-MS/MS, GC-MS), spectroscopy (UV-Vis, FTIR, Raman), and other relevant physiochemical characterization methods. * Regulatory Knowledge: In-depth knowledge of cGMP, ICH guidelines, and other global regulatory requirements pertaining to analytical method development, validation, and quality control. Additional Preferences * Problem-Solving Skills: Demonstrated ability to independently troubleshoot complex analytical challenges, conduct OOS investigations, and implement effective solutions. * Leadership & Mentorship: Proven ability to provide technical leadership, mentor junior scientists, and influence technical direction within a team or project. * Communication Skills: Excellent written and verbal communication skills, with the ability to present complex scientific information clearly and concisely to diverse audiences. * Collaboration: Strong interpersonal skills with a proven ability to collaborate effectively in a cross-functional team environment. * Innovation: Demonstrated track record of identifying and implementing new analytical technologies or approaches to solve scientific problems. 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. 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. 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. 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. 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. 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. Position Brand Description: The Supervisor of Tank Farm, Truck & Rail Operations is directly responsible for managing the operations for their respective area and shift. The Supervisor will be responsible for tank farm operations, air emissions systems, and truck/rail loading and unloading. The Supervisor is the management representative on shift. The role is responsible for the supervision of operators involved in the direct execution of operations (per SOPs and operational execution instructions) in order to safely and compliantly support the manufacturing of high-quality medicine. The Supervisor provides leadership and ensures that appropriate staffing is in place. The role will ensure equipment is maintained in a state of compliance and processes in a validated state for their respective area and shift. In the project delivery phase and startup phase of the project (startup expected 2026 to 2028), 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 Objectives/Deliverables: Daily Operations/Business Management: * Build and promote a strong Safety and Quality culture. Maintain a safe working environment and conduct operations activities in a manner that protects safety, environment and quality. * Ensure operations maintain compliance with all regulatory requirements at all times. * Ensure tank farm, truck and rail loading and unloading areas appropriately support the execution of the production plan for the site. * Ensure consistency of operations on designated shift through active engagement on the floor. * Ensure audit action items assigned to operations are completed in a timely manner. * Enter Trackwise/Veeva events, participate in and lead CAPA investigations * Set objectives and development plans for operators. Respond to employee relations issues with operators on shift and escalate to management where necessary. * Manage events as required, ensuring appropriate communication within the team and with external teams. Provide input to investigations. * Build and develop a team, creating clear common purpose and promoting good team spirit. * Ensure that operators are appropriately trained, and that operating procedures and training material are available and current. * Communicate appropriately with operators regarding site objectives and team business. * Ensure the team is adequately resourced to meet the business objectives appropriately managing overtime as necessary. Specifically, during the startup phase of the Lebanon API site (2025 to 2027) leadership will be expected to be collaborative, inclusive, and support the broader team to: * Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of operational excellence. * Develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge and practices where necessary, but also incorporating external experiences and learning. * Ensure regulatory compliance and operational excellence by supporting lean principles in their respective area. * Support the project team as they deliver the facility to the site team, by providing feedback and support. 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. * Demonstrated leadership experience * Minimum 5 years of previous experience in chemical/manufacturing operations Additional Preferences: * Bachelor's or Associate's Degree in science, engineering, or technical field * Previous experience in facility/area start-up environments * Previous experience in tank farm or truck and rail loading and unloading * Skills in providing/receiving feedback and creating employee development plans * Basic computer skills (desktop software) are required. * Solid understanding of FDA guidelines and cGMP requirements. * Strong organizational skills and ability to handle and prioritize multiple requests. * Strong technical aptitude and ability to train and mentor others. * Ability to work with a team, make independent decisions, and influence diverse groups. * Ability to instill teamwork within the shift and demonstrate key interpersonal skills. Additional Information: * Ability to work 12-hour rotating shifts * Ability to work overtime as required. * Depending on the candidate's experience, the position may require a short-term assignment of 6-12 months within Indianapolis, IN and/or 1-3 months domestically/internationally 1-3 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory. 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 $40.38 - $59.23 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. 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. 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 and start up 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 TS/MS team will own all areas of technology transfer, process validation, and process stewardship. Position Description: Bioprocess - Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture. The successful candidate will be required to build deep technical expertise in their area of responsibility (including in-depth knowledge of the science behind the molecule and the process), have strong working skills on the manufacturing equipment set and control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities. They may also work to ensure that the process is in-control, capable, compliant, and maintained in a validated state through continual monitoring and may play a role in by implementing new technologies and process improvements in the manufacturing environment. Key Objectives/Deliverables * Have an in-depth knowledge of the science behind the molecule and the processes. Understand the process control strategy for gene therapy products * Provide technical support for all start-up TS/MS activities (e.g., NPI, tech transfer, process validation, process stewardship and improvement) * Ownership and technical stewardship of bioprocess and provide technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes * Work as part of cross-functional teams, and establish partnerships with applicable functions, operations, and development to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team * Be able to assess whether the process is in control and capable of meeting its stated purpose and is in a constant state of validation * Identify process improvements and participate in implementation of Lean manufacturing initiatives * Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents and annual reports * Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda * Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability * Serve as technical interface external to the Lebanon site * Provide audit support, as needed * Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. * Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities Basic Requirements: * Bachelor's in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field * 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering Additional Preferences: * Have an in-depth knowledge of the science behind the molecule and the processes on mRNA/LNP drug substance manufacturing. Understand the process control strategy for mRNA/LNP mediated gene therapy products * Experience and understanding of technical challenges with mRNA as a therapeutic modality is required * Experience with mRNA/LNP formulation * Experience with QC assays in line with product CQAs including variability * Strong interpersonal and teamwork skills * Strong self-management and organizational skills * Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization * Experience with data trending and analysis * Ability to analyze complex data and solve problems * Demonstrated successful membership/leadership of cross-functional teams 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. 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

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 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 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, Laboratory and Analytical equipment application 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 software design, coding/configuration and testing (sequence logic, graphics, batch software etc.) * Automation Engineering including design, tuning and troubleshooting of control loops * Implementing and supporting 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 * 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 major Pharmaceutical manufacturing handling Laboratory and Analytical systems and equipment, and Systems Integration. and minimum of 2+ years working experience in Biopharma engineering, operations, or manufacturing. * Experience in commissioning, qualifying and supporting Analytical equipment such as cell counters, environmental testing, filter testing, etc. Additional Preferences: * Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI). * Experience in facilitating and driving decision-making at an organizational level. Other Information: * Initial location at Lilly Technology Center, Indianapolis. * Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. 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 - $143,000 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. 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. 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 software design, coding/configuration and testing (sequence logic, graphics, batch software etc.) * Automation Engineering including design, tuning and troubleshooting of control loops * Implementing and supporting 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 * 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 major Pharmaceutical manufacturing handling Laboratory and Analytical systems and equipment, and Systems Integration. * 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, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI). * Experience in commissioning, qualifying and supporting Analytical equipment such as cell counters, environmental testing, filter testing, 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