Lilly & Company jobs in Concord, NC

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization Overview** For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. **Position Description** 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 $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Values / Objectives **Integrity** + Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. + Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. + Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. **Excellence** + Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. + Responsible for administering technical training and ensuring all operators are trained to perform tasks. + Operate the equipment and perform activities as required to meet production schedule. + Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) + Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. **Respect for People** + Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. + Key liaison between operations and support functions. Basic Qualifications/Requirements: **Time Commitments and Work Authorization** + Minimum education: High School Diploma or GED + A valid drivers license + Must Pass a "fitness for duty" physical exam + 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. + Must pass a vision exam and be free of color blindness + Must be equivalent to 20/20 correctable close vision acuity + Must be able to work a 2-2-3 schedule Additional skills/preferences: **Experience with** **, completion of,** **or understanding of:** + We have several levels open for Operator which are based on the experience and education you bring. + Ability to work overtime as required + Ability to wear safety equipment (glasses, shoes, gloves, etc) + Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. + Ability to participate in professional development opportunities (team coursework such as classes through RCCC) + Ability to effectively communicate (electronically, written and verbal) + Flexibility - the ability to troubleshoot and triage challenges + Computer proficiency (desktop software, MS office). + Leadership and the ability to train / educate team members + STEM degree or certifications + Aseptic filling, single use assemblies, isolator technology. + Automated, semi-automated, and/or manual inspection. + Knowledge of current Good Manufacturing Practices (CGMPs) + Experience in operations or manufacturing environments. + Pharmaceutical, medical device or food processing industries + Manufacturing Execution Systems and electronic batch release. + Continuous improvement (Lean, Six Sigma methodologies) + Highly automated equipment (inspection, packaging, filling, assembly, etc) + SAP, Electronic Batch Records 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 entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. **Responsibilities:** + Assess differences in current sterility assurance programs across the sites and drive harmonization + Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. + Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. + Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. + Building, maintaining, and growing capability across the organization in the sterility assurance space + Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. + Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. + Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. + Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. + Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. + Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections + Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals **Basic Qualifications:** + BS Degree required. + MS/PhD in a biological science preferred. + 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. + 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. + Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) + Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities + Strong written and oral communication skills + Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology + Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance + Demonstrated experience influencing site and network leaders to advance technical agenda projects **Additional Preferences:** + Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. + Support the establishment of a sterility assurance network or hub in global TSMS + Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance + Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space + Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance + Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. + Strong capability to influence personnel and management across the organization + Close interaction with quality to enable internal audits that identify risks + Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. **Additional Information:** + Approximately 25% travel _Lilly currently_ _anticipates_ _that the base salary for this position could range from between_ $133,500 _to_ $220,000 _and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. 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). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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._ 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 $133,500 - $246,400 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. Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. 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 and embody our company values of Integrity, Excellence, and Respect for People Position Description 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 $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. **Integrity** + Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. + Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. + Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. **Excellence** + Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. + Responsible for administering technical training and ensuring all operators are trained to perform tasks. + Operate the equipment and perform activities as required to meet production schedule. + Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) + Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. **Respect for People** + Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. + Key liaison between operations and support functions. **Education, Experience, and Skills** + We have several levels open for Operator which are based on the experience and education you bring. + Minimum education: High School Diploma or GED + Ability to effectively communicate (electronically, written and verbal) + Flexibility - the ability to troubleshoot and triage challenges + Computer proficiency (desktop software, MS office). + A valid driver's license. + Must pass a vision exam and be free of color blindness + Must be equivalent to 20/20 correctable close vision acuity **Time Commitments and Work Authorization** + Ability to work 6pm to 6am on a 2-2-3 schedule + Must Pass a "fitness for duty" physical exam + Ability to work overtime as required + Ability to wear safety equipment (glasses, shoes, gloves, etc.) + Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. + Ability to participate in professional development opportunities (team coursework such as classes through RCCC) + Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipateproviding sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. **Experience with** **, completion of,** **or understanding of:** + Leadership and the ability to train / educate team members + STEM degree or certifications + Formulation, dispensing, material preparation + Knowledge of current Good Manufacturing Practices (CGMPs) + Experience inoperations or manufacturing environments. + Pharmaceutical, medical device or food processing industries + Manufacturing Execution Systems and electronic batch release. + Continuous improvement (Lean, Six Sigma methodologies) + Highly automated equipment(inspection, packaging, filling, assembly, etc) + SAP, Electronic Batch Records 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. **Organization Overview:** 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 $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord 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. This is an opportunity you don't want to miss! **Job Responsibilities:** The Quality Assurance Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The QA Batch Disposition is responsible for final disposition of Semi-Finished and/or Finished drug combination products. The QA position is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility. Electronic batch records with high integration and focus on data integrity will be utilized to confirm manufacturing production. + Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems + Performs final batch disposition of semi-finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner + Effectively own/review/approve GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls) + Additional job duties as required **Basic Requirements:** + Bachelor's degree in STEM + Experience working in the pharmaceutical or medical device industry in QA roles + Previous batch disposition experience + Ability to make technical decisions, provide guidance to the site + Proficiency with applicable computer systems + Demonstrated strong oral and written communication skills + Demonstrated interpersonal skills and the ability to work as a team + Root cause analysis/troubleshooting skills + Demonstrated attention to detail and ability to maintain quality systems + Previous regulatory inspection readiness and inspection execution experience + Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites + Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals + 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 employment positions on the B or S paths or at levels M1-M2 or R1-R4. **Additional Skills/Preferences:** + Ability to work 8-hour days - Wednesday through Sunday Day Shift (not eligible for remote work) **Ability to work overtime and be on-call as required** + Proven ability to work independently or as part of a Team to resolve an issue + Previous experience with Event and Change Management process + Proficiency with SAP, MES, and Trackwise + Previous experience with device and parenteral product materials 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. For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. **Position Description:** The Senior / Principal Sterility Assurance Scientist is a technical role that assists in development and implementation of the site's sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. **Key Objectives/Deliverables:** + Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification. + Lead and/or provide technical oversight for developing the site's environmental monitoring program, aseptic process simulation program. + Lead and/or provide technical oversight for developing the site's contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies. + Provide technical expertise and/or oversight for the facility's cleanroom gowning and aseptic technique strategy/program. + Assist with providing sterility assurance expertise for site procedures, processes, protocols, validations, and technical studies. + Author and evaluate sterility assurance risk assessments to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination. + Assist in the development and implementation of site process flows to ensure effective contamination control strategies are established. + Lead or provide technical support for root cause investigations associated with sterility assurance programs. + Participate and/or provide technical sterility assurance support during internal and external audits. + Create, execute, and/or review/evaluate technical documents and change controls related to sterility assurance programs. + Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives. **Minimum Requirements:** + Bachelor's or master's degree in microbiology, Biology, Biochemistry, or other related scientific discipline. + Minimum of 2 years' experience working in sterile pharmaceutical manufacturing within a Microbiology, Technical Services/Manufacturing Sciences, Sterility Assurance, or other related department with applicable experience in Sterility Assurance programs/strategies. + Relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing. **Additional Preferences:** + Possess strong interpersonal skills to work cross-functionally within a team. + Possess strong self-management and organizational skills. + Possess strong technical writing skills. + Possess strong oral and written communication skills for communicating to colleagues, management, and other departments. + Experience with data analysis and trending. + Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing, warehouse, or laboratory areas. + Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities. **Other Information:** + The role will be phased from a project support role to a routine support role as the development facility and processes progress. + Tasks may require repetitive motion and standing or walking for long periods of time. + Ability to have a flexible schedule during the project phase to support qualification activities as required. + Travel may be required during the project phase for training and implementation of sterility assurance programs. The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. 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. + **Main Purpose and Objectives of Position:** The Process Safety Engineer is part of the Lilly API Health, Safety, and Environmental (HSE) team and provides technical leadership and expertise in the development, implementation, and maintenance of process safety management and engineering support services to a Lilly API site, including the construction, startup, and operations phases.In the project delivery and startup phase of the project (startup expected 2025 to 2027), the HSE 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 for this role include:** + Support the development and implementation of the process safety management operational readiness plan for a Lilly API facility as a collaborative, inclusive, and energetic member of the HSE team. + Support the project team to deliver the facility as a key stakeholder providing input and feedback on process safety design decisions, construction, and startup plans while ensuring decisions meet project deliverables and compliance requirements, leveraging existing Lilly knowledge, and incorporating external experiences and learning. + Provide oversight and support of process hazard analysis and facility siting studies. + Develop and roll out process safety management (PSM) program elements such as employee participation, Management of Change, Pre-Startup Safety Review, Process hazard analysis (PHA), etc. + Provide training, mentoring, and onboarding of new staff to help support a strong process safety culture at the site. + Provide oversight of operations of pharmaceutical API manufacturing units. + Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, ensure safety and compliance of new systems, and assist in setting requirements to ensure safe startup. + Ensure application of industry codes and standards such as NPFA 30 (combustible liquids), NFPA 652 (combustible dust), and overpressure protection requirements during project and management of change reviews. + Build technical relationships by routinely interacting with corporate and site process safety colleagues. This role has opportunities to network externally with organizations such as the Center for Chemical Process Safety (CCPS), Purdue Process Safety and Assurance Center (P2SAC), and the ACC Process Safety networking groups. **Requirements:** + Bachelor's degree in chemical engineering, chemistry, or related field of study; CCPSC or PE preferred + Minimum 2 years of experience in chemical or pharmaceutical manufacturing **Additional Preferences:** + Knowledge and experience in process safety, including knowledge of OSHA Process Safety Management (PSM) regulation + Trained in Process Hazard Analysis, HAZOP, and What-If Methodologies + Strong analytical skills and systematic and structured way of working + Strong collaboration and communication skills + Trained in Process Hazard Analysis facilitation + Trained in Layer of Protection Analysis (LOPA) + Knowledge of EPA Risk Management Plan + Experience interfacing with HSE-related regulatory agencies **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 new site area will be required. Additional information will be provided during the interview process. 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 $63,000 - $92,400 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. **Quick Benefits Overview:** - Medical, Dental, Vision, Prescription benefits are effective on your first day of employment - Paid vacation- starting annually at 120 hours (prorated based on start date) - Shift Bonus for Weekend hours - Sign-on bonus For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. **Responsibilities:** The focus of the Maintenance Technician - Night Shift is to provide maintenance expertise to service, repair, and maintain process and utility other pharmaceutical manufacturing equipment currently in service. The Maintenance Technician - Night Shift is expected to understand the needs and requirements of the customer (Operations); must be able to work effectively with customers, handle customer questions with tact and understanding while displaying good customer service. **Key Objectives/Deliverables:** - This role is expected to improve equipment uptime, line efficiency, and increase overall equipment effectiveness in a production environment by condition monitoring, troubleshooting, and assisting in engineering changes. - Must possess a good mechanical aptitude to troubleshoot and repair equipment while, following departmental rules and regulations. - Must be willing to work with safety as a primary focus and abide by applicable safety procedures and practices. - Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance). - Perform repairs and overhaul equipment (e.g., gear boxes, pumps, blowers, fans and drives) to include disassembly, setting tolerances, aligning, resetting timing (e.g., air compressors, vacuum pumps) - Setup equipment to design specifications (e.g., timing, leveling, alignment) - Operate precision alignment equipment (e.g., Roma-align, lasers, etc.) - Must have the ability to quickly and accurately diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime. - Must accurately document the actions taken to repair the equipment in the CMMS program. - Willing to assist in areas outside of their primary responsibility and learn other skills, as required **Basic Qualifications:** - High school diploma/GED - Minimum 2 Years of Maintenance - 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 - Must satisfy background check and drug screening requirements. **Additional Skills/Preferences:** - Must be able to speak, read and write English at a sufficient level to communicate technical and business information effectively. - Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite and other required software programs. - Must be able to effectively work in a team environment. - Physical considerations include the ability to work with or around equipment, climb ladders and stairs and use PPE (Personal Protective Equipment). He/she may be exposed to harsh weather conditions as part of the job. - Good, all-around hands-on experience with repair of equipment. - Use basic trouble shooting equipment such as multi-meters, calipers ect. **Additional Information:** - Overtime may be required during shutdowns, emergency situations, or periods of heavy workloads. - The Maintenance Technician - Night Shift will work in and around potentially dangerous and hazardous equipment, powders, liquids and gases. Safety is paramount for this position. - Night shift role. Will transition to a night shift 12-hr 2-2-3 schedule in the future. For the training period, it will be a day shift role. 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 $21.27 - $46.88 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. Territory position- ROCK HILL, SC CMH1 - 170243 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 Territory Manager will be accountable for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly portfolio. This includes customers in multiple HCP specialties, as well as representatives in key hospital accounts. They will be viewed as a credible expert and resource supporting all medicines and appropriate brand patients. The Territory Manager will be accountable for driving results by embracing Lilly's suite of models: Lilly Selling Model, Lilly Competency Model and Account Management Model to meet the needs of customers through strong execution. Territory Managers will drive consistent ways of working within the Regional Healthcare Market. They will build relationships with key customers to drive utilization and adoption of our medicines for the right patients. Specific responsibilities include the following: BUSINESS OWNERSHIP - Promotes the full portfolio of priority products with multiple HCP specialties. - Understands the marketplace within the territory; evaluates and tailors the territory strategy to grow and own business outcomes. - Navigates the ever-changing healthcare environment and payer landscape to increase understanding of accounts and be able to impact key stakeholders to become trusted partners. - Utilizes appropriate business insight tools, data, and analytics to identify trends, priorities, opportunities, and potential obstacles. - Implements and adopts new technologies, including the integration of AI company-approved tools and other analytical capabilities to streamline customer interactions. - Identifies and advocates for new opportunities to enhance the customer experience. - Models a growth mindset to create positive experiences. SELLING SKILLS / CUSTOMER EXPERIENCE - Embraces and uses the company's selling, competency and account management models to elevate performance and drive results. - Demonstrates high learning agility to understand disease state, marketplace, clinical trials, and product label. - Promotes the BU portfolio by planning for and engaging in patient-centered dialogues with customers. EXECUTION / RESULTS - Promotes across BU-portfolio and across HCP specialties, driving consistent ways of working within the Regional Health Care Market to meet customers' needs. Appropriately, fully utilizes the Virtual Medical Hub. - Achieves targeted sales and execution metrics while adhering to company policies and procedures. - Owns the customer relationship for product promotion, on-label medical questions, and general market access. - Holds self-accountability for results and performance across all accounts, from individual HCPs to large health systems. - Builds and maintains relationships with both internal and external partners to foster trust and create collaborative success. BASIC QUALIFICATIONS - Bachelor's degree. - Professional certification or license required to perform this position if required by a specific state. - Valid US driver's license and acceptable driving record is required. - Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. ADDITIONAL SKILLS / PREFERENCES - Demonstrated business ownership skills, selling/customer experience skills, and execution/results. - Account based selling experience. Ability to identify and engage staff members in accounts. - Strong learning agility, self-motivation, team focused, and emotionally intelligent. - Bilingual skills as aligned with territory and customer needs. - Residence within 30 miles of the territory boundary. 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 $63,000 - $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 entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord 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. This is an opportunity you don't want to miss! The OpEx team provides leadership in operational excellence and continuous improvement efforts by combining knowledge of pharmaceutical manufacturing with OpEx principles and tools. The focus of the OpEx Site Business Partner role is to partner with all organizational levels across local and global business to deploy operational excellence standards and support both event and nonevent-based continuous improvement. Results include, but are not limited to, cycle time reduction, increased asset effectiveness, cost reduction, improved quality, as well as increased employee morale at all levels due to more time being spent on patient value-added activities. **Key Role Deliverables:** + Provide direct support for operational excellence/ continuous improvement projects with functional areas/departments in support of site production targets and delivery of siteagenda. + Establish and support implementation of lean manufacturing initiatives in alignment with the Lilly Manufacturing Standards of Operational Excellence (MSOEs). + Monitor/build a strong safety culture andholdothers accountable while leading byexample. + Ensure consistency of operations across shifts through active engagement on the shop floor through Gemba walks (Practice vs. Procedure evaluations). + Lead cross functional teams in the development and implementation of the followingproblem-solvingmethodologies and initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Value Stream Mapping,A3etc. + Deliver necessary information and data about the new/ongoing CIprojects. + Facilitates problem-solving, shared learning and decision-making across plantfunctions + Responsible forschedule tracking,updating,and reporting to all stakeholders for CI projects. + Responsible forassembling Continuous Improvement (CI) project plans, teamwork assignments, directing and monitoring work efforts daily. + Escalates technical and timeline issues appropriately for CI projects. + Identifiesissues that may delay project deliverables andrecommendrisk mitigation strategies, contingencies, and actions, whenappropriate. + Other duties as assigned. **Systems & Strategies - Design and Governance** : + Lead the establishment of operational excellence systems within the operationalorganization,including DailyManagement System (DMS) to drive process improvement or streamline operational activities to increase operational efficiencies. + Facilitate and execute the process of systems governance and assessment (Lean Maturity Assessment; Site CI OpEx Self-Assessments) + Capture benefits ofoperational excellenceimprovement program and report to siteleadership **Assisting** **in Engagements:** + Lead and / or partner on a variety of engagements, within the site/function as well as network level within Manufacturing and Quality.Driving the process / projects to completion. + Lead and coach process improvement opportunities and projects according to selectedmethodology(Kaizen Event, A3,etc...) + Provide support to ensure robust Organizational Change Management and Monitoring Plans are in place to sustainimprovements. + Engage routinely with sponsors to provide status updates and escalate whereappropriate asissuesarise. + Ensure Lean principles and toolsare integratedinto both project execution and solutiondesign. + Partner with site leadership/ other functions, including site lead team and other governance forums, toidentifyand prioritize major productivity improvement opportunities. Leverage internal and external networking. **Instructing and Training Others:** + Facilitate CI & OpEx training to all levels of employees within assigned areas to support deployment and ongoing sustainability of CI and OpEx / Lean ways of working. **Minimum** **Requirements** + Demonstrated strong written and oral communication and interpersonal interaction skillsto be able to work effectively in a team-based environment. + Strong self-management and organizational skills. + Ability tocoach individuals at all levels, and leadproject teams + Ability to influence without authority. + Relevant operations experience in a GMP facility. + Pharmaceutical experience + Knowledge ofc GMPs + Experience in lean manufacturing or other productivity industry methods + Bachelor'sor equivalent + Day shiftwithpossibleafter hoursupport + Project delivery maycoincidewith companyholidays + Occasional travel mayberequiredfor training, conferences,project facilitation,etc. 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 $58,500 - $137,500 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. **Position Description** **Company Overview** At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. 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 and embody our company values of **Integrity** , **Excellence** , and **Respect for People** **Position Overview** 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 $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Operations Supervisor will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to; train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities. This position will require travel domestically (2-4 week trips and/or 3-9 month short term assignments) with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently. Once the facility is turned over to operations, the Supervisor role is responsible for leadership of the team that operates the multiple PAR. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators. As a site leader and expert at our growing site, there will be significant opportunities for growth into future leadership and technical roles. **Key Responsibilities** **Integrity** + Leading by examples with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation. + Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. + Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. **Excellence** + Collaborate with area supervisors to ensure a high standard of; communication, best practice sharing, and consistency across the groups and different shifts. + Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence. + Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value. + Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence. + Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation. + Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality. **Respect for People** + Support the site in building a diverse, empowered, and capable team. + Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift. + Responsible for the coaching, development, and performance evaluation of operators. + Communicate cross functionally with support team if there are quality, equipment, operational concerns. **Requirements (Education, Experience, Training)** **Education, Experience and Skills** + High School Diploma or equivalent + Prior supervisory experience + Basic computer skills (desktop software, MS Office) are required. + Previous experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable). + Excellent interpersonal, written, and oral communication skills + Strong organizational skills and ability to handle and prioritize multiple requests. + Strong technical aptitude and ability to train and mentor others. **Time Commitments and Work Authorization** + Ability to work overtime as required + Ability to wear safety equipment (glasses, shoes, gloves, etc) + Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. + The position may require a short term assignment of 3, 6, or 9 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. + 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. **Preferred attributes but not required** **Experience with, completion of, or understanding of:** + 4+ years in manufacturing/operations with 2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + STEM degree or certification + Aseptic filling, single use assemblies, isolator technology. + Automated, semi-automated, and/or manual inspection. + Highly automated equipment (inspection, packaging, filling, assembly, etc.) + Manufacturing Execution Systems and SAP or other electronic business systems + Continuous improvement methodologies and mindset - lean, six sigma, etc. + Root cause analysis and implementing corrective actions + Ability to organize and motivate teams + Facility, Equipment, Systems, Start-up 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 $35.33 - $57.12 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. **Position Brand Description:** This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team. This includes but is not limited to; all facets of inspections (PAI/PLI/Surveillance/Post-approval/for-cause) for all global Health Authorities. Support HA reporting (FAR, BPDR, OUS requirements). Provide support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as the need arises including completion of annual changes. **Key Objectives/Deliverables:** In this role the individual provides support that they provide to the different programs are as shown below. Primary focus is compliance support; other duties will depend on business needs. **Compliance Support** + Lead inspection readiness activities + Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes. + Proficient in application and use of Machine Learning and analytical tools to being continuously in a state of inspection ready. **US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues** + Works with numerous stakeholders to ensure HA reporting as required to meet all Global regulations/requirements **Global and US Recall / Market Withdrawal** + Supports the coordination of the execution activities related to US product recall and withdrawals. + Participate in periodic product withdrawal/recall simulations. + Consult and train local recall coordinators to assure understanding of process for product removal. + Monitors recall activities of partner organizations globally. + Provide information for use in various periodic reviews or metrics. **Global and US Product Shortage** + Coordinate and execute product shortage reporting for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory, Global Patient Safety, Qualified Persons at Affiliates and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure. + Provide information for use in various periodic reviews or metrics. **Drug and Device Establishment Registration** + Determine information required for drug and device establishment registration for all manufacturers of US marketed product, such as importers, agent, and function. + Update drug and device establishment registrations for changes as required including completion of annual registrations. **US Volume Reporting** + Coordinate and execute annual volume reporting for US + Provide information for use in various periodic reviews or metrics. **Personal Development and Shared Learning** + Be continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements + Continue to gain knowledge vital to provide a greater understanding of GxP requirements + Participate in applicable external industry groups and forums **Minimum Requirements:** + Bachelor's degree - Preferred degree in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences. + Minimum of 5 years relevant Industry or Health Authority experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs **Additional Preferences:** + Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing + Expertise in data driven approaches to assess site compliance + Experience in Quality Assurance or GxP function + Strong compliance knowledge + Excellent communication and presentation skills: ability to deliver constructive feedback + Skilled in interpreting and applying standards to diverse situations with strong problem-solving ability + Ability to work independently and collaboratively with minimal supervision + Significant experience supporting global inspections and compliance programs **Other Information:** + Maintain awareness of regulatory and industry tends; ensure corporate standards remain current. + Flexibility to effectively prioritize work activities to meet regulated timelines. + Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management. + Must be available to travel (domestic and international) when required (estimated at 25%, might increase based on business needs). + Role can be remote or based at any Lilly site/affiliate, corporate headquarters. Preference is at a Lilly site/affiliate or headquarters. This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements may change over time and may include additional responsibilities not specifically described in the job description. 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 $126,000 - $204,600 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** As part of Corporate Engineering, the Global Robotics Program (GRP) is responsible for the design, delivery, and oversight of robotic applications across all Lilly manufacturing sites around the globe. This includes testing new technologies, delivering proof of concepts, designing robotic systems, and deploying site robotic systems in partnership with site resources. **Core Responsibilities** + Lead the effective deployments and Commissioning & Qualification efforts of robotic systems by working in multi-disciplinary teams within manufacturing sites, quality, and other business units. + Work with vendors to solve, shakedown, and oversee Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities. + Develop capabilities in robotics and PLC programming to effectively troubleshoot design and/or functional issues at manufacturing site and/or vendor locations. + Author and/or Review site documentation (ie: test cases, design documents) for assigned robotic systems deployed to sites. + Work closely with the Robotics Platform Owner to support the design of robotic systems. + Be a champion for safety, compliance, and quality best practices when delivering robotic systems to manufacturing sites. + Support GRP lab activities and application development in areas including robotic system design, 2D and 3D vision development, robot code development, , augmented / virtual reality simulation, and augmented / virtual reality simulation. + Provide technical mentoring to Lilly engineers related to the deployment and utilization of robotic technologies, including serving as a Peer Coach to new robotics engineers in the department. **Other Responsibilities** + Work with Global Facilities Delivery (GFD), GRP Platform Owners, and manufacturing sites to support profiling new robotic systems or technologies. + Support the development of Engineering Best Practices and Engineering Standards for robotic application development. + Participate in multi-functional teams within manufacturing, quality, and other business units when developing new robotic systems. **Basic Qualifications:** + Bachelor's or masters in an engineering field + **Ability to travel (50%) domestically and/or internationally up to 1-2 weeks per month** + Minimum 5 years of relevant manufacturing experience, preferably in discrete pharmaceutical manufacturing: + parenteral filling and/or inspection processes + device assembly or packaging processes + additional industries may be considered such as automotive, or other high-speed manufacturing processes + Experience in Automation Controls, Mechanical Assemblies for highly automated systems + Experience in Project Delivery, Commissioning & Qualification, Validation Activities, and cGMP Regulations + Experience in control system troubleshooting, programming, and integration with PLC (Rockwell Studio5000), HMI/SCADA (FactoryTalk View Studio SE), Fanuc Robotics, 3DV, and Cognex vision systems. **Additional Skills/Preferences:** + Knowledge in AutoCAD and SolidWorks + Proven ability to communicate effectively to customers, business partners, and staff including good oral, written, and visual presentations + Demonstrated ability to use and implement various tools, systems, and processes resulting in improved operational excellence + Proficiency in working cross-functionally to deliver on highly complex tasks that may have aggressive timelines + Demonstrated ability to work within and lead diverse, cross-functional teams (engineering, manufacturing, operations, tech scientists, quality, etc.) + Demonstrated ability to interpret and apply solutions to different situations by understanding customer needs and/or applying strong problem-solving skills **Additional Information:** + Significant domestic and international travel will be required + Will require work in a construction and manufacturing environment; safety equipment and/or gowning may be required + This is NOT a remote position 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 $63,000 - $165,000 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. Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up. The Principal Scientist/Engineer - Cleaning Validation/Sterilization Validation - Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objectives include the start-up and compliant manufacturing of products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the Concord site. **Key Objectives / Deliverables:** · Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. · Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs. · Development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc). · Support periodic requalification activities for production equipment and systems. · Author and support the execution of validation protocols and reports. · Provide technical guidance to the Process Team for cleaning and sterilization processes. · Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities. · Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. · Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes. · Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed. · 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, procedures, PFDs, VMPs, APRs, QPPAs, etc. · 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. · Serve as cleaning and sterilization interface external to the Concord site. · Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. · Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain. · Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities. **Minimum Requirements:** · BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline · 3+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.) **Additional Preferences:** · In depth knowledge of parenteral drug product manufacturing · Experience executing equipment qualification, cleaning validation, and sterilization validation · Demonstrated successful leadership of cross-functional teams · Experience with data trending and analysis · Ability to analyze complex data and solve problems **Other Information:** · Role is Monday through Friday based. · 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 Concord site with ability to travel to Indianapolis and other global Lilly sites as required 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. **Responsibilities** : The Scientist - TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual inspection (VI), although may support multiple areas during start-up phase. Upon the start of commercial production, this role's objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The role will also author and execute protocols as well as conduct root cause investigations. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to parenteral manufacturing. **Key Objectives/Deliverables:** - Support the assigned Process Team (formulation, filling, or VI) as TSMS representative. - (Associate/Senior) Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team. - Represent Concord TSMS team for internal and external communications on a regular basis - Lead risk management activities as it pertains to product/process - Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues - Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc. - Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability - Identify opportunities and lead technical projects to improve process control and/or productivity - Serve as interface with upstream suppliers and parenteral product networks - Drive stability strategy for Concord products - Provide Audit support as needed - Identify opportunities and participate in projects to improve process control and/or productivity **Basic Qualifications:** - Bachelor's degree or higher an engineering, packaging science, or related field **Additional Skills/Preferences:** - Pharmaceutical and/or medical device manufacturing experience - Root Cause Investigation Experience - Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP - Demonstrated successful leadership of cross-functional teams - Strong interpersonal and teamwork skills - Strong self-management and organizational skills **Additional Information:** - Role is Monday through Friday. 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. 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. **Position Description** **Company Overview** At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. 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 are looking for people who are determined to make life better for people around the world and embody our company values of **Integrity** , **Excellence** , and **Respect for People** **Position Overview** Lilly is investing over $1 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need. If you ever wanted to have a direct impact on building a team's culture and on how the team operates, now is the perfect opportunity! During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) areas which include formulation, aseptic isolator barrier filling, and visual inspection areas. This position will require travel domestically with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently Once the facility is turned over to operations, the AD role is responsible for ensuring the group meets annual production goals as well as planning through 1-3 year horizons. They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational excellence, compliance, and continuous improvement. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates. As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles. **Key Objectives / Deliverables** **Integrity** + Leading by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation. + Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups + Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions. **Excellence** + Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations. + Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve. + Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE). + Understand and influence the manufacturing control strategy for their area. **Respect for People** + Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area. + Responsible for a work force of approximately 40 - 70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them. + Provide leadership and develop objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people. + Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety. + Leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support. + Represent their Operations Process Team on the Plant Flow (value stream) Team. **Requirements (Education, Experience, Training)** **Education, Experience, and Capabilities** + Bachelor's degree in a STEM or pharmaceutical related field of study. + At least 7 years working in the pharmaceutical industry. + Previous management or leadership experience including leading or working effectively with a cross functional group. + Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA. + Excellence in; interpersonal, electronic, written, and oral communication + Strong technical aptitude and ability to train and mentor others **Time Commitments, Environment, and Work Authorization** + Ability to wear safety equipment (glasses, shoes, gloves, etc) + Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives. + Position will involve frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and to build global network. + Travel domestically and internationally, up to approximately 20% of the year to learn and network with colleagues. **Preferred attributes but not required** **Experience with, completion of, or understanding of:** + 6+ years in manufacturing/operations with 4+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + Aseptic filling, single use assemblies, isolator technology. + Automated, semi-automated, and/or manual inspection. + Highly automated equipment (inspection, packaging, filling, assembly, etc.) + Creation of standard operating procedures, work instructions, and training documentation. + Equipment & Facility design documentation reviews + Facility, equipment, or system start up. + Qualification and process validation experience. + Manufacturing Execution Systems and electronic batch release. + Automated Storage and Retrieval System (ASRS) Warehouses or AGVs. + Continuous improvement methodologies and mindset - lean, six sigma, etc. + Documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat) This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 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 $123,000 - $180,400 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. **Engineering Technician - Night Shift** **At Lilly** , we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global leader in healthcare, committed to discovering life-changing medicines, advancing disease management, and supporting our communities through philanthropy and volunteerism. We put people first and strive to make a meaningful impact every day. **Position Summary** The Engineering Technician at our Concord, NC facility plays a key role in supporting Parenteral Operations, our customer, by ensuring the efficient setup and operation of Pre-Filled Syringe and Isolator Equipment. This position requires hands-on engineering maintenance expertise to assist with equipment setup, operational support, troubleshooting, repairs, and ongoing maintenance. The ideal candidate will demonstrate a strong understanding of customer needs, collaborate effectively with internal teams, and provide responsive, courteous support. Success in this role requires technical proficiency, problem-solving skills, and a commitment to delivering excellent customer service in a dynamic manufacturing environment. **Key Responsibilities** + Promote a safety-first, quality-always culture in all tasks and interactions + Improve equipment uptime, line efficiency, and overall equipment effectiveness (OEE) + Perform condition monitoring, troubleshooting, and provide operational support + Diagnose and repair precision filling equipment with strong mechanical aptitude + Collaborate with engineering and production teams to resolve equipment issues promptly + Assist with equipment setup and changeovers to support production needs + Adhere to all GMP and quality standards + Must have the ability to quickly and accurately diagnose the root cause of a problem and properly implement corrective actions to minimize downtime + Accurately document maintenance activities and corrective actions + Support cross-functional tasks and assist outside primary responsibilities as needed + Work independently and manage priorities under pressure **Basic Qualifications** + High school diploma or GED + Minimum of 5 years' experience in production maintenance + Strong mechanical aptitude and hands-on technical skills + Proficient with basic hand tools + Detail-oriented with a commitment to quality and precision + Familiarity with safety protocols and proper PPE usage + Physically able to stand for extended periods + Effective team player with strong interpersonal skills **Preferred Qualifications** + Associate's degree or technical certification in a related field is a plus + Knowledge of FDA and GMP regulations + Experience operating high-speed, automated production equipment, preferably Syringe/Vial Filling systems utilizing Isolator technology + Ability to quickly learn and apply new procedures + Experience working in a classified manufacturing environment + Familiarity with Computerized Maintenance Management Systems (CMMS) platforms + Strong verbal and written communication skills + Customer-oriented mindset with a proactive approach + Analytical thinker with strong problem-solving abilities **Additional Information** + Flexibility to work overtime or adjust schedule based on production demands + Following a Monday-Friday, 8-hour training period, the role transitions to a 12-hour 2-2-3- **night shift** schedule + Willing and able to respond to off-hour emergencies as needed + Open to travel for training and professional development opportunities 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 $21.27 - $46.88 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 Sr. Principal Engineer - Maintenance and Calibration Lead is expected to bring key expertise, technical leadership, and knowledge in the areas of maintenance, asset reliability, and calibration management. This individual will be responsible for managing and sustaining best practices at Concord related to maintenance and calibration activities across the site. This role will have direct supervision of the calibration team, overseeing staff responsible for calibration activities. This role will have responsibility for program development and sustainability while working with dedicated workstreams that perform maintenance on equipment. This individual will have responsibilities for reporting site compliance to corporate standards and guidelines for maintenance. This individual will lead technical analysis, solution development through personal expertise, application of engineering principles and good engineering practices, project management skills, and direct interactions with manufacturing sites and functional areas. **Key Objectives/Deliverables:** Concord Site Project Development Responsibilities + Act as Business Owner during the design, construction, and start-up of the portion of the campus dedicated to support maintenance and calibration services + Partner with Global Facilities Delivery (GFD), Engineering and Construction Companies, other design partners and more broadly the project team to provide input during the design phase of equipment and Concord facility on maintenance related items + Partner with Global Facilities Delivery (GFD), Construction and Design Build firms and more broadly the project team to ensure smooth transition handoff from construction to start up. Maintenance Program Responsibilities + Develop and manage maintenance governance frameworks and standardized workflows across the site to drive consistency, compliance, and operational excellence. + Monitor, report, and escalate site maintenance metrics and key performance indicators to relevant stakeholders, ensuring transparency and timely resolution of issues. + Lead continuous improvement initiatives to optimize maintenance processes, enhance equipment reliability, and support a culture of innovation and efficiency. + Ensure the Computerized Maintenance Management System (CMMS) is fully functional, accurate, and used effectively in compliance with quality standards and regulatory requirements. + Oversee MRO (Maintenance, Repair, and Operations) activities, including the procurement and inventory management of spare parts, to guarantee material availability and cost-effective operations. Calibration Services Manager + Supervise calibration engineers by overseeing their work, providing guidance, ensuring compliance, coordinating assignments, and supporting their professional growth to maintain high-quality calibration services. + Manage relationships with third-party calibration service providers, ensuring that contracted services meet site standards for accuracy and reliability. + Oversee the documentation and traceability of calibration records, ensuring that all data is accurately maintained and readily available for audits and inspections Establish and maintain calibration schedules for all critical equipment, ensuring compliance with regulatory standards and internal quality requirements. + Coordinate with cross-functional teams to resolve calibration discrepancies, investigate root causes, and implement corrective actions as necessary. + Support training initiatives for staff involved in calibration activities, promoting adherence to best practices and continuous improvement. **Basic Qualifications:** + BS engineering or Equivalent Work Experience + Demonstrated technical leadership skills + 5 years of Maintenance and CMMS related experience + 5 years of Calibration related experience in an FDA or equivalent facility + Experience with deviations and corrective and preventive actions (CAPA) + Experience interfacing with regulators during quality and safety audits **Additional Skills/Preferences:** + Previous experience with Maximo (GMARS) + Green site start-up experience This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 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. **Operator - Device Assembly** 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. **Company Overview** At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. 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 and embody our company values of **Integrity** , **Excellence** , and **Respect for People** **Position Description** 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 $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Device Assembly Operators (Entry to Lead roles) will support start up activities required to bring the area into service. They will become the experts within their assigned area and educate their team in the proper operation of the equipment. The Expert and Lead roles are expected to become the leaders for the device assembly equipment and process and will lead the training of new staff. This position will require travel (2-4 week trips and/or 2-6 month short term assignments) domestically with the opportunity for travel internationally during the first year to collaborate, train with, and learn from sites who currently produce our medicines. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, collaborating cross-functionally, and holding all to our safety first / quality always mindset. Expert and Lead Operators will coordinate daily activities to meet capacity plans while developing their own and our team's capabilities. As an expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. **Key Objectives / Deliverables** **Integrity** + Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. + Act as technical experts for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. **Excellence** + Technical Expert: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. + Responsible for assistance administering technical training and ensuring all operators are trained to perform tasks. + Operate the equipment and perform activities as required to meet production schedule with a safety first and quality always mindset. + Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) + Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. **Respect for People** + Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Device Assembly area. + Key liaison between operations and support functions. **Requirements (Education, Experience, Training)** **Education, Experience, and Skills** + We have several levels open for Operator which are based on the experience and education you bring. + Minimum education: High School Diploma or GED + Ability to effectively communicate (electronically, written and verbal) + Flexibility - the ability to troubleshoot and triage challenges + Computer proficiency (desktop software, MS office). **Time Commitments and Work Authorization** + Must Pass a "fitness for duty" physical exam + During the project phase the working schedule will vary (typically M-F 8 hrs). In operation, must have the ability to work 12-hour shift (2-2-3 structure). + Ability to work overtime as required + Ability to wear safety equipment (glasses, shoes, gloves, etc) + The position will require a short term assignment of 3, 6, or 9 months domestically to train, be certified on existing processes, and establish contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory. + 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. **Preferred attributes but not required** **Experience with, completion of, or understanding of:** + (Expert and Lead roles) Leadership and the ability to train / educate team members + STEM degree or certifications + Knowledge of current Good Manufacturing Practices (CGMPs) + Experience in operations or manufacturing environments. + Pharmaceutical, medical device or food processing industries + Manufacturing Execution Systems and electronic batch release. + Continuous improvement (Lean, Six Sigma methodologies) + Highly automated equipment (inspection, packaging, filling, assembly, etc) + SAP, Electronic Batch Records 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. As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). \#WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. + **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