McDonald's Corporation
Chicago, Illinois
Company Description: McDonald's evolving Accelerating the Arches growth strategy puts our customers and people first, and leverages our competitive advantages to strengthen our brand. We are recognized on lists like Fortune's Most Admired Companies and Fast Company's Most Innovative Companies. Doubling Down on the 4Ds (Delivery, Digital, Drive Thru, and Development) Our growth pillars emphasize the important role technology plays as the leading, global omni-channel restaurant brand. Technology enables the organization through digital technology, and improving the customer, crew and employee experience each and every day. Global Technology forging the way Leading the digitization of our business is the Technology organization made up of intrapreneurs who build industry defining tech using the latest innovations and platforms, like AI and edge computing to deliver on the next set of cutting-edge opportunities for the business. At McDonald's you get to solve technology innovation challenges at an incredible scale, and work across global teams who are always hungry for a challenge. This provides access to exciting career paths for technologists. It's bonus points when you get to see your family and friends use the tech you build at their favorite McD restaurant. Check out the Global Technology Technical Blog to learn how technology is directly enabling the Accelerating the Arches strategy. Job Description: This opportunity is part of the Global Technology Infrastructure & Operations team (GTIO), where our mission is to deliver modern and relevant technology that supports the way McDonald's works. We provide best-in-class foundational technology products and services including Global Networking, Cloud, End User Computing, and IT Service Management. It's our goal to always provide an engaging, relevant, and simple experience for our customers. The Technical Product Manager, Restaurant Hardware Solutions, is part of the Restaurant Infrastructure & Operations team within Global Technology. This role reports to the Senior Technical Product Manager and is responsible for leading a portfolio of restaurant hardware solutions.The restaurant environment is complex, made up of many different technology hardware solutions. With constantly evolving needs of restaurant crew and customers, this team plays an important role in understanding those needs and evolving our hardware solutions to keep pace. Being a new team, the Technical Product Manager will play a key role in defining the scope of the Hardware Solutions team portfolio and associated hardware lifecycle processes - including evolution of Infrastructure as a Service capabilities related to restaurant hardware. This is an exciting opportunity for an experienced technology leader to help shape the transformation of infrastructure and operations products and services to the entire McDonalds environment. Responsibilities & Accountabilities: Support the Senior Manager, Restaurant Hardware solutions, by executing short-term strategy for a portfolio of hardware solutions (e.g., digital menu boards) Understand restaurant needs (crew, customer, manager) and translate those functional and technical needs into product requirements to be used in designing and/or selecting a hardware product, as well as continuous enhancement of the product Partner with market and cross-functional teams to define standards / technical specifications, select and approve global solutions, and certify new hardware solutions With a shift to expanded global standards and hardware as a service, the Technical Product Manager will contribute to defining market-level installation and ongoing technical support for products within their domain. Contribute to the performance of the team by overseeing work of suppliers and related teams Solve defined problems; identify ways to modify processes to meet end customer needs (e.g. operator or customer challenges with a particular hardware solution) Define and enforce hardware solution quality standards Design and execute tests to guarantee up-time of hardware solutions in the markets; oversee third party hardware certification testing where appropriate Provide input on deployment plan for hardware solutions to market teams Facilitate processes to maintain and support hardware in the markets Manage stakeholder relationships, including product teams as customers of hardware solutions, and ensure stakeholders are aligned with hardware roadmaps. Qualifications: Basic Qualifications Willingness and ability to live the McDonald's values every day: Serve, Inclusion, Integrity, Community, and Family. Demonstrated experience owning and delivering high load technology or hardware products with measurable results. Experience partnering with stakeholders across a complex, global organization. Experience prioritizing product feature development and cost/benefit analysis (e.g. business case creation, MVP define & develop, backlog prioritization) Impact-minded approach, with ability to articulate goals and instill action and alignment to reach them. Experience working in an agile product development environment: participating in and leading agile ceremonies, managing a backlog/release plan, tracking metrics of multiple teams, removing blockers (burndown chart, release burn up, etc.) Demonstrated ability to manage technical products from an unclear problem statement, driving clarity, understanding, and opportunity assessment, managing trade-offs and evaluating potential concepts with internal and external partners using design thinking and agile principles. Experience managing technical priorities and driving strategic hardware initiatives. Ability to utilize data to proactively identify and solve complex problems potentially impacting the restaurant infrastructure platform function. Proven analytical and quantitative skills; ability to use data and metrics to back up assumptions, develop product strategy and business cases, and measure success. Strong written communication, presentation, and interpersonal skills, with the ability to convey complex ideas in easy-to-understand business friendly language. Understand customer centricity, and lead products with that mindset. Preferred Qualifications Experience with hardware peripherals, architecture, and cataloging processes. Example hardware: kiosks, digital signage, media players, scanners, cash recyclers, audio systems, etc. Experience with infrastructure as a service (IaaS) Demonstrated ability to effectively influence and partner across product and platform teams within a global engineering organization Demonstrated ability to manage and navigate to drive results within a globally distributed organization Experience defining hardware standards and specifications that address global complexities and differences between markets / regions Experience managing P&L of a program and developing/managing financial forecasts to communicate ROI and spend rate Experience 8+ years of technical product management or relevant experience with a Bachelor's degree or 6+ years relevant experience with a Master's degree. 2+ years working with restaurant or retail hardware solutions and platforms. Experience working on technical teams that manage an important product and/or a suite of products. Experience communicating with leadership and setting expectations for major cross-functional initiatives. Additional Information: McDonald's is committed to providing qualified individuals with disabilities reasonable accommodations to perform the essential functions of their jobs. Additionally, if you (or another applicant of whom you are aware) require assistance accessing or reading this job posting or otherwise seek assistance in the application process, please contact McDonald's provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex, sex stereotyping, pregnancy (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), race, color, religion, ancestry or national origin, age, disability status, medical condition, marital status, sexual orientation, gender, gender identity, gender expression, transgender status, protected military or veteran status, citizenship status, genetic information, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Nothing in this job posting or description should be construed as an offer or guarantee of employment.
Company Description: McDonald's evolving Accelerating the Arches growth strategy puts our customers and people first, and leverages our competitive advantages to strengthen our brand. We are recognized on lists like Fortune's Most Admired Companies and Fast Company's Most Innovative Companies. Doubling Down on the 4Ds (Delivery, Digital, Drive Thru, and Development) Our growth pillars emphasize the important role technology plays as the leading, global omni-channel restaurant brand. Technology enables the organization through digital technology, and improving the customer, crew and employee experience each and every day. Global Technology forging the way Leading the digitization of our business is the Technology organization made up of intrapreneurs who build industry defining tech using the latest innovations and platforms, like AI and edge computing to deliver on the next set of cutting-edge opportunities for the business. At McDonald's you get to solve technology innovation challenges at an incredible scale, and work across global teams who are always hungry for a challenge. This provides access to exciting career paths for technologists. It's bonus points when you get to see your family and friends use the tech you build at their favorite McD restaurant. Check out the Global Technology Technical Blog to learn how technology is directly enabling the Accelerating the Arches strategy. Job Description: This opportunity is part of the Global Technology Infrastructure & Operations team (GTIO), where our mission is to deliver modern and relevant technology that supports the way McDonald's works. We provide best-in-class foundational technology products and services including Global Networking, Cloud, End User Computing, and IT Service Management. It's our goal to always provide an engaging, relevant, and simple experience for our customers. The Technical Product Manager, Restaurant Hardware Solutions, is part of the Restaurant Infrastructure & Operations team within Global Technology. This role reports to the Senior Technical Product Manager and is responsible for leading a portfolio of restaurant hardware solutions.The restaurant environment is complex, made up of many different technology hardware solutions. With constantly evolving needs of restaurant crew and customers, this team plays an important role in understanding those needs and evolving our hardware solutions to keep pace. Being a new team, the Technical Product Manager will play a key role in defining the scope of the Hardware Solutions team portfolio and associated hardware lifecycle processes - including evolution of Infrastructure as a Service capabilities related to restaurant hardware. This is an exciting opportunity for an experienced technology leader to help shape the transformation of infrastructure and operations products and services to the entire McDonalds environment. Responsibilities & Accountabilities: Support the Senior Manager, Restaurant Hardware solutions, by executing short-term strategy for a portfolio of hardware solutions (e.g., digital menu boards) Understand restaurant needs (crew, customer, manager) and translate those functional and technical needs into product requirements to be used in designing and/or selecting a hardware product, as well as continuous enhancement of the product Partner with market and cross-functional teams to define standards / technical specifications, select and approve global solutions, and certify new hardware solutions With a shift to expanded global standards and hardware as a service, the Technical Product Manager will contribute to defining market-level installation and ongoing technical support for products within their domain. Contribute to the performance of the team by overseeing work of suppliers and related teams Solve defined problems; identify ways to modify processes to meet end customer needs (e.g. operator or customer challenges with a particular hardware solution) Define and enforce hardware solution quality standards Design and execute tests to guarantee up-time of hardware solutions in the markets; oversee third party hardware certification testing where appropriate Provide input on deployment plan for hardware solutions to market teams Facilitate processes to maintain and support hardware in the markets Manage stakeholder relationships, including product teams as customers of hardware solutions, and ensure stakeholders are aligned with hardware roadmaps. Qualifications: Basic Qualifications Willingness and ability to live the McDonald's values every day: Serve, Inclusion, Integrity, Community, and Family. Demonstrated experience owning and delivering high load technology or hardware products with measurable results. Experience partnering with stakeholders across a complex, global organization. Experience prioritizing product feature development and cost/benefit analysis (e.g. business case creation, MVP define & develop, backlog prioritization) Impact-minded approach, with ability to articulate goals and instill action and alignment to reach them. Experience working in an agile product development environment: participating in and leading agile ceremonies, managing a backlog/release plan, tracking metrics of multiple teams, removing blockers (burndown chart, release burn up, etc.) Demonstrated ability to manage technical products from an unclear problem statement, driving clarity, understanding, and opportunity assessment, managing trade-offs and evaluating potential concepts with internal and external partners using design thinking and agile principles. Experience managing technical priorities and driving strategic hardware initiatives. Ability to utilize data to proactively identify and solve complex problems potentially impacting the restaurant infrastructure platform function. Proven analytical and quantitative skills; ability to use data and metrics to back up assumptions, develop product strategy and business cases, and measure success. Strong written communication, presentation, and interpersonal skills, with the ability to convey complex ideas in easy-to-understand business friendly language. Understand customer centricity, and lead products with that mindset. Preferred Qualifications Experience with hardware peripherals, architecture, and cataloging processes. Example hardware: kiosks, digital signage, media players, scanners, cash recyclers, audio systems, etc. Experience with infrastructure as a service (IaaS) Demonstrated ability to effectively influence and partner across product and platform teams within a global engineering organization Demonstrated ability to manage and navigate to drive results within a globally distributed organization Experience defining hardware standards and specifications that address global complexities and differences between markets / regions Experience managing P&L of a program and developing/managing financial forecasts to communicate ROI and spend rate Experience 8+ years of technical product management or relevant experience with a Bachelor's degree or 6+ years relevant experience with a Master's degree. 2+ years working with restaurant or retail hardware solutions and platforms. Experience working on technical teams that manage an important product and/or a suite of products. Experience communicating with leadership and setting expectations for major cross-functional initiatives. Additional Information: McDonald's is committed to providing qualified individuals with disabilities reasonable accommodations to perform the essential functions of their jobs. Additionally, if you (or another applicant of whom you are aware) require assistance accessing or reading this job posting or otherwise seek assistance in the application process, please contact McDonald's provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex, sex stereotyping, pregnancy (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), race, color, religion, ancestry or national origin, age, disability status, medical condition, marital status, sexual orientation, gender, gender identity, gender expression, transgender status, protected military or veteran status, citizenship status, genetic information, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Nothing in this job posting or description should be construed as an offer or guarantee of employment.
Eli Lilly and Company
Durham, North Carolina
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: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) 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.
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: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) 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.
Eli Lilly and Company
Durham, North Carolina
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 designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance 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 RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) 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.
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 designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance 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 RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) 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.