Senior Principal Engineer jobs at Takeda Pharmaceuticals U.S.A., Inc.

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Senior CQV Engineer to join our team at our office located in _____________. In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients. Additional Responsibilities Write C/Q/V documents following established standards and templates, including but not limited to the following: Commissioning Forms C/Q/V Protocols and Summary Reports Standard Operating Procedures Impact Assessments Specifications (URS/FRS/DDS) FATS/SATs Perform field/site activities including, but not limited to, the following: Attend and witness FATs and SATs as a representative of IPS clients. Execution of commissioning forms and witnessing of vendor start-up and testing. Execution of C/Q/V protocols. Walkdown and verification of system drawings (P&IDs, as-builts, etc.) Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required. Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. Come join our dynamic team that creates world-class designs for our clients, and propel your career to new horizons! Qualifications & Requirements Bachelor of Science in Engineering. This is an entry-level position. 7 or more years of relevant experience. Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software. General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA. Context & Safety This position will have up to 100% travel to the site, or as required by the assigned project. You may be assigned to a client site for an extended period. Overnight travel or staying in the city of the client's location is possible depending on the assignment. Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan. You may visit active construction sites and will be required to take site safety training and adhere to site safety rules. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!

SummaryWe are seeking an experienced senior-level Software Engineer to join our Algorithm development team. This role will focus on implementing advanced algorithms and software for cutting-edge medical devices, with a focus on real-time signal processing and system integration. The ideal candidate will have a strong background in technical computing and software development, work with stakeholders on different stages of the software development process and support a high functioning team effectively.Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Responsibilities: Work with key stakeholders to design and implement real-time signal processing algorithms for embedded and x86-based systems. Translate prototype algorithms (Python/MATLAB) into production-grade C# or C/C++ code. Optimize and profile code for performance and reliability. Collaborate with product software teams to integrate algorithms into system architecture for deployment on medical devices. Support software lifecycle activities including algorithm design documentation, testing, and verification. Requirements: A Bachelor's Degree in computer sciences, electrical engineering or relevant field with a strong background in software development, mathematics and signal processing and 10+ years of direct industry experience is required for this position (15+ years of experience preferred). Must Have: Strong hands-on programming experience in C# and C/C++ (Windows, Linux). Programming experience in Python, MATLAB, or similar scientific programming language. Experience with CI/CD (Continuous Integration/Continuous Deployment) frameworks such as Azure DevOps and Pipelines. Experience in the design, optimization, integration and validation of complex real-time data processing algorithms. Proficiency in software development tools, such as IDEs (e.g. Visual Studio, PyCharm) and source control (e.g. Git). Knowledge of software development methodologies and best practices, e.g. object-oriented design, design patterns, code analysis, development processes, etc. Experience or working knowledge in product design control process, e.g. product requirements, test protocols and reports. Excellent teamwork, partnering, and communication skills. Nice to Have: Experience in developing software for medical devices (or in a similarly regulated environment) is preferred. Knowledge in Machine/Deep Learning algorithms and related programming experience is preferred. Experience in optimizing software for embedded targets. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Irvine Laguna CanyonAdditional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $124,700.00 - $205,800.00 USD Annual

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The basic purpose of this role is to autonomously lead full stack Data Analytics software configurations for global and regional Data Analytics Product Groups. The Sr. Principal Solutions Engineer, Data Analytics is responsible for continuous design, development, configuration and maintenance of parameterized contextualization schemes relative to Manufacturing Science and Technology data science requirements. This role leads collaboration among global business stakeholders and site leadership teams; including Global IT, and Global Engineering. The incumbent will participate in the Advanced Analytics Strategy Forums to drive enterprise data management and systems architectural requirements. The primary expectation of this role is to be a world class expert in Data Analytics Computer Science. This includes proficiency in full stack data management supporting pharmaceutical and bio-pharmaceutical data sciences/advanced analytics. The incumbent is expected to work independently and coordinate global efforts on clean structured data acquisitions, data transformations, and data integration efforts required to enable statistical modeling, visualization, reporting, and interpretation of results. This role will coordinate the preparation of Quality Risk Assurance based data integrity and validation reports with appropriate business acumen for stakeholder interpretations and qualifications. The Sr. Principal Solutions Engineer, Data Analytics will manage junior level Data Engineers to provide analysis-ready batch contextualized vector and attribute data to statisticians and data scientists for applications of generalized linear modeling, time-series multivariate statistics including Principal Components Analysis and Partial Least Squares, QC test method validations, ANOVA/means comparisons, and univariate and multivariate Statistical Process Control (SPC) methodologies. This position is expected to collaborate and represent Data Analytics best practices to promote a broad Analytical Engineering ecosystem that delivers financial business value. This role will identify and implement new commercial and open-source software technologies that support more effective and efficient data science user experiences across multiple sites and programs. Duties & Responsibilities Sr. Principal Solutions Engineer, Data Analytics Executes the duties of data management and software configurations for complex pharmaceutical batch analytics. Maintains a high level of business acumen and data science knowledge to ensure the fit, form, and function of data science software. Collaborates with Data Analytics management, team, and stakeholders, to set and achieve project goals. Assumes departmental responsibility for multiple projects; capable of working independently to deliver objectives in a timely manner and capable of compiling industry standard reports suitable for internal compliance and/or regulatory submission. For projects of diverse complexity, provides architectural configuration support for all process historians, ERP, LIMS, and Electronic Batch Systems. Identifies and implements new commercial and open-source software technologies that support more effective and efficient data science user experiences across multiple sites and programs. Conducts periodic review of LAN, WAN, Edge servers in regional data centers and software architectures relative to data transfer rates and create data flow latency summarizations to ensure optimum user experiences for data scientists and local users. Continuously ensures agile software and data management effectiveness to support standard and advanced data science programs and product groups. Receives feedback and adjusts program management effectiveness from Global MSAT, Strategic site stakeholders and leadership, IT Governance bodies, and Global Engineering. Clearly communicates all aspects of data management requirements and functionality relative to Advanced Analytics outcomes to a diverse group of global stakeholders at all levels and locations of the organization. Maintains cutting edge industrial knowledge including a demonstrated ability to interpret and adapt primary literature, trade forums, and user meetings evaluating and when profitable, adapting new/emerging technologies to ongoing projects to enhance Data Analytics Product Groups. Principal Solutions Engineer, Data Analytics Executes the duties of data management and software configurations for complex pharmaceutical batch analytics. Responsible for maintaining a general level of business acumen and data science knowledge to ensure the fit, form, and function of data science software. Collaborates with Global MSAT Data Analytics management, team, and stakeholders, to set and achieve project goals. For projects of diverse complexity, provides configuration support for all process historians, ERP, LIMS, and Electronic Batch Systems. Helps perform feasibility studies for commercial and open-source software technologies identified by team leadership with the intent of more effective and efficient data science user experiences across multiple sites and programs. Conducts periodic review of LAN, WAN, Edge servers in regional data centers and software architectures relative to data transfer rates and create data flow latency summarizations to ensure optimum user experiences for data scientists and local users. Participates in agile software and data management standards to support advanced data science programs and product groups. Receives feedback and adjusts program management effectiveness from Global MSAT, Strategic site stakeholders and leadership, IT Governance bodies, and Global Engineering. Clearly communicates all aspects of data management requirements and functionality relative to Advanced Analytics outcomes to a diverse group of global stakeholders at all levels and locations of the organization. Requirements Sr. Principal Solutions Engineer, Data Analytics Bachelor's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field. In addition to bachelor's degree, a minimum of ten (10) years' experience supporting pharmaceutical or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. OR Master's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field and a minimum of seven (7) years supporting pharmaceutical and/or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. OR PhD in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field and a minimum of four (4) years supporting pharmaceutical and/or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. Required programming proficiency: C#, SQL, Graph, GO, Javascript, NoSQL. Required software experience: OSIsoft PI, PI AF, Libre, ETL Data Warehouse Design and Implementation, Grafana, SIMCA, SIMCA-online, SAS JMP, Visual Studio, MS DB Mgmnt Studio, MongoDB, PostgreSQL, Kubernetes, RedHat OpenShift. Desired Proficiency: R, Python, Rust, Swift. Demonstrated experience pro-actively identifying/detecting design issues and recommending solutions in global architectures and database design and implementations supporting global networks. Leadership experience managing others to successful outcomes with earned value. Demonstrated ability to: Perform tasks typically expected of a Data Engineer. Convey analytical thinking as well as business acumen and technical knowledge. Work effectively as part of a team and manage project(s) from a data management perspective. Determine appropriate database design, development, and configurations to deliver efficient architectural approach for advanced analytics. Principal Solutions Engineer, Data Analytics Bachelor's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field. In addition to relevant Bachelor's Degree, a minimum of seven (7) years applied computer science/data analytics experience in manufacturing industry, pharmaceutical, bio-pharmaceutical or related organization. OR Relevant Master's Degree and a minimum of four (4) years applied computer science/data analytics in manufacturing industry, pharmaceutical, bio-pharmaceutical or related organization. Academic and Demonstrated Knowledge of C#, SQL, Graph, GO, Javascript, NoSQL, Recommended software experience: OSIsoft PI, PI AF, Libre, ETL Data Warehouse Design and Implementation, Grafana, SIMCA, SIMCA-online, SAS JMP, Visual Studio, MS DB Mgmt Studio, MongoDB, PostgreSQL, Kubernetes, RedHat OpenShift. Desired Proficiency: R, Python, Rust, Swift. Ability to perform tasks typically expected of a Data Engineer. Desired Skills, Experience and Abilities

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The basic purpose of this role is to autonomously lead full stack Data Analytics software configurations for global and regional Data Analytics Product Groups. The Sr. Principal Solutions Engineer, Data Analytics is responsible for continuous design, development, configuration and maintenance of parameterized contextualization schemes relative to Manufacturing Science and Technology data science requirements. This role leads collaboration among global business stakeholders and site leadership teams; including Global IT, and Global Engineering. The incumbent will participate in the Advanced Analytics Strategy Forums to drive enterprise data management and systems architectural requirements. The primary expectation of this role is to be a world class expert in Data Analytics Computer Science. This includes proficiency in full stack data management supporting pharmaceutical and bio-pharmaceutical data sciences/advanced analytics. The incumbent is expected to work independently and coordinate global efforts on clean structured data acquisitions, data transformations, and data integration efforts required to enable statistical modeling, visualization, reporting, and interpretation of results. This role will coordinate the preparation of Quality Risk Assurance based data integrity and validation reports with appropriate business acumen for stakeholder interpretations and qualifications. The Sr. Principal Solutions Engineer, Data Analytics will manage junior level Data Engineers to provide analysis-ready batch contextualized vector and attribute data to statisticians and data scientists for applications of generalized linear modeling, time-series multivariate statistics including Principal Components Analysis and Partial Least Squares, QC test method validations, ANOVA/means comparisons, and univariate and multivariate Statistical Process Control (SPC) methodologies. This position is expected to collaborate and represent Data Analytics best practices to promote a broad Analytical Engineering ecosystem that delivers financial business value. This role will identify and implement new commercial and open-source software technologies that support more effective and efficient data science user experiences across multiple sites and programs. Duties & Responsibilities Sr. Principal Solutions Engineer, Data Analytics Executes the duties of data management and software configurations for complex pharmaceutical batch analytics. Maintains a high level of business acumen and data science knowledge to ensure the fit, form, and function of data science software. Collaborates with Data Analytics management, team, and stakeholders, to set and achieve project goals. Assumes departmental responsibility for multiple projects; capable of working independently to deliver objectives in a timely manner and capable of compiling industry standard reports suitable for internal compliance and/or regulatory submission. For projects of diverse complexity, provides architectural configuration support for all process historians, ERP, LIMS, and Electronic Batch Systems. Identifies and implements new commercial and open-source software technologies that support more effective and efficient data science user experiences across multiple sites and programs. Conducts periodic review of LAN, WAN, Edge servers in regional data centers and software architectures relative to data transfer rates and create data flow latency summarizations to ensure optimum user experiences for data scientists and local users. Continuously ensures agile software and data management effectiveness to support standard and advanced data science programs and product groups. Receives feedback and adjusts program management effectiveness from Global MSAT, Strategic site stakeholders and leadership, IT Governance bodies, and Global Engineering. Clearly communicates all aspects of data management requirements and functionality relative to Advanced Analytics outcomes to a diverse group of global stakeholders at all levels and locations of the organization. Maintains cutting edge industrial knowledge including a demonstrated ability to interpret and adapt primary literature, trade forums, and user meetings evaluating and when profitable, adapting new/emerging technologies to ongoing projects to enhance Data Analytics Product Groups. Principal Solutions Engineer, Data Analytics Executes the duties of data management and software configurations for complex pharmaceutical batch analytics. Responsible for maintaining a general level of business acumen and data science knowledge to ensure the fit, form, and function of data science software. Collaborates with Global MSAT Data Analytics management, team, and stakeholders, to set and achieve project goals. For projects of diverse complexity, provides configuration support for all process historians, ERP, LIMS, and Electronic Batch Systems. Helps perform feasibility studies for commercial and open-source software technologies identified by team leadership with the intent of more effective and efficient data science user experiences across multiple sites and programs. Conducts periodic review of LAN, WAN, Edge servers in regional data centers and software architectures relative to data transfer rates and create data flow latency summarizations to ensure optimum user experiences for data scientists and local users. Participates in agile software and data management standards to support advanced data science programs and product groups. Receives feedback and adjusts program management effectiveness from Global MSAT, Strategic site stakeholders and leadership, IT Governance bodies, and Global Engineering. Clearly communicates all aspects of data management requirements and functionality relative to Advanced Analytics outcomes to a diverse group of global stakeholders at all levels and locations of the organization. Requirements Sr. Principal Solutions Engineer, Data Analytics Bachelor's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field. In addition to bachelor's degree, a minimum of ten (10) years' experience supporting pharmaceutical or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. OR Master's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field and a minimum of seven (7) years supporting pharmaceutical and/or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. OR PhD in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field and a minimum of four (4) years supporting pharmaceutical and/or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. Required programming proficiency: C#, SQL, Graph, GO, Javascript, NoSQL. Required software experience: OSIsoft PI, PI AF, Libre, ETL Data Warehouse Design and Implementation, Grafana, SIMCA, SIMCA-online, SAS JMP, Visual Studio, MS DB Mgmnt Studio, MongoDB, PostgreSQL, Kubernetes, RedHat OpenShift. Desired Proficiency: R, Python, Rust, Swift. Demonstrated experience pro-actively identifying/detecting design issues and recommending solutions in global architectures and database design and implementations supporting global networks. Leadership experience managing others to successful outcomes with earned value. Demonstrated ability to: Perform tasks typically expected of a Data Engineer. Convey analytical thinking as well as business acumen and technical knowledge. Work effectively as part of a team and manage project(s) from a data management perspective. Determine appropriate database design, development, and configurations to deliver efficient architectural approach for advanced analytics. Principal Solutions Engineer, Data Analytics Bachelor's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field. In addition to relevant Bachelor's Degree, a minimum of seven (7) years applied computer science/data analytics experience in manufacturing industry, pharmaceutical, bio-pharmaceutical or related organization. OR Relevant Master's Degree and a minimum of four (4) years applied computer science/data analytics in manufacturing industry, pharmaceutical, bio-pharmaceutical or related organization. Academic and Demonstrated Knowledge of C#, SQL, Graph, GO, Javascript, NoSQL, Recommended software experience: OSIsoft PI, PI AF, Libre, ETL Data Warehouse Design and Implementation, Grafana, SIMCA, SIMCA-online, SAS JMP, Visual Studio, MS DB Mgmt Studio, MongoDB, PostgreSQL, Kubernetes, RedHat OpenShift. Desired Proficiency: R, Python, Rust, Swift. Ability to perform tasks typically expected of a Data Engineer. Desired Skills, Experience and Abilities

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The basic purpose of this role is to autonomously lead full stack Data Analytics software configurations for global and regional Data Analytics Product Groups. The Sr. Principal Solutions Engineer, Data Analytics is responsible for continuous design, development, configuration and maintenance of parameterized contextualization schemes relative to Manufacturing Science and Technology data science requirements. This role leads collaboration among global business stakeholders and site leadership teams; including Global IT, and Global Engineering. The incumbent will participate in the Advanced Analytics Strategy Forums to drive enterprise data management and systems architectural requirements. The primary expectation of this role is to be a world class expert in Data Analytics Computer Science. This includes proficiency in full stack data management supporting pharmaceutical and bio-pharmaceutical data sciences/advanced analytics. The incumbent is expected to work independently and coordinate global efforts on clean structured data acquisitions, data transformations, and data integration efforts required to enable statistical modeling, visualization, reporting, and interpretation of results. This role will coordinate the preparation of Quality Risk Assurance based data integrity and validation reports with appropriate business acumen for stakeholder interpretations and qualifications. The Sr. Principal Solutions Engineer, Data Analytics will manage junior level Data Engineers to provide analysis-ready batch contextualized vector and attribute data to statisticians and data scientists for applications of generalized linear modeling, time-series multivariate statistics including Principal Components Analysis and Partial Least Squares, QC test method validations, ANOVA/means comparisons, and univariate and multivariate Statistical Process Control (SPC) methodologies. This position is expected to collaborate and represent Data Analytics best practices to promote a broad Analytical Engineering ecosystem that delivers financial business value. This role will identify and implement new commercial and open-source software technologies that support more effective and efficient data science user experiences across multiple sites and programs. **Duties & Responsibilities** **Sr. Principal Solutions Engineer, Data Analytics** + Executes the duties of data management and software configurations for complex pharmaceutical batch analytics. + Maintains a high level of business acumen and data science knowledge to ensure the fit, form, and function of data science software. + Collaborates with Data Analytics management, team, and stakeholders, to set and achieve project goals. + Assumes departmental responsibility for multiple projects; capable of working independently to deliver objectives in a timely manner and capable of compiling industry standard reports suitable for internal compliance and/or regulatory submission. + For projects of diverse complexity, provides architectural configuration support for all process historians, ERP, LIMS, and Electronic Batch Systems. + Identifies and implements new commercial and open-source software technologies that support more effective and efficient data science user experiences across multiple sites and programs. + Conducts periodic review of LAN, WAN, Edge servers in regional data centers and software architectures relative to data transfer rates and create data flow latency summarizations to ensure optimum user experiences for data scientists and local users. + Continuously ensures agile software and data management effectiveness to support standard and advanced data science programs and product groups. + Receives feedback and adjusts program management effectiveness from Global MSAT, Strategic site stakeholders and leadership, IT Governance bodies, and Global Engineering. + Clearly communicates all aspects of data management requirements and functionality relative to Advanced Analytics outcomes to a diverse group of global stakeholders at all levels and locations of the organization. + Maintains cutting edge industrial knowledge including a demonstrated ability to interpret and adapt primary literature, trade forums, and user meetings evaluating and when profitable, adapting new/emerging technologies to ongoing projects to enhance Data Analytics Product Groups. **Principal Solutions Engineer, Data Analytics** + Executes the duties of data management and software configurations for complex pharmaceutical batch analytics. + Responsible for maintaining a general level of business acumen and data science knowledge to ensure the fit, form, and function of data science software. + Collaborates with Global MSAT Data Analytics management, team, and stakeholders, to set and achieve project goals. + For projects of diverse complexity, provides configuration support for all process historians, ERP, LIMS, and Electronic Batch Systems. + Helps perform feasibility studies for commercial and open-source software technologies identified by team leadership with the intent of more effective and efficient data science user experiences across multiple sites and programs. + Conducts periodic review of LAN, WAN, Edge servers in regional data centers and software architectures relative to data transfer rates and create data flow latency summarizations to ensure optimum user experiences for data scientists and local users. + Participates in agile software and data management standards to support advanced data science programs and product groups. + Receives feedback and adjusts program management effectiveness from Global MSAT, Strategic site stakeholders and leadership, IT Governance bodies, and Global Engineering. + Clearly communicates all aspects of data management requirements and functionality relative to Advanced Analytics outcomes to a diverse group of global stakeholders at all levels and locations of the organization. **Requirements** **Sr. Principal Solutions Engineer, Data Analytics** + Bachelor's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field. + In addition to bachelor's degree, a minimum of ten (10) years' experience supporting pharmaceutical or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. OR + Master's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field and a minimum of seven (7) years supporting pharmaceutical and/or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. OR + PhD in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field and a minimum of four (4) years supporting pharmaceutical and/or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. + Required programming proficiency: C#, SQL, Graph, GO, Javascript, NoSQL. + Required software experience: OSIsoft PI, PI AF, Libre, ETL Data Warehouse Design and Implementation, Grafana, SIMCA, SIMCA-online, SAS JMP, Visual Studio, MS DB Mgmnt Studio, MongoDB, PostgreSQL, Kubernetes, RedHat OpenShift. + Desired Proficiency: R, Python, Rust, Swift. + Demonstrated experience pro-actively identifying/detecting design issues and recommending solutions in global architectures and database design and implementations supporting global networks. + Leadership experience managing others to successful outcomes with earned value. Demonstrated ability to: + Perform tasks typically expected of a Data Engineer. + Convey analytical thinking as well as business acumen and technical knowledge. + Work effectively as part of a team and manage project(s) from a data management perspective. + Determine appropriate database design, development, and configurations to deliver efficient architectural approach for advanced analytics. **Principal Solutions Engineer, Data Analytics** + Bachelor's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field. + In addition to relevant Bachelor's Degree, a minimum of seven (7) years applied computer science/data analytics experience in manufacturing industry, pharmaceutical, bio-pharmaceutical or related organization. + OR + Relevant Master's Degree and a minimum of four (4) years applied computer science/data analytics in manufacturing industry, pharmaceutical, bio-pharmaceutical or related organization. + Academic and Demonstrated Knowledge of C#, SQL, Graph, GO, Javascript, NoSQL, + Recommended software experience: OSIsoft PI, PI AF, Libre, ETL Data Warehouse Design and Implementation, Grafana, SIMCA, SIMCA-online, SAS JMP, Visual Studio, MS DB Mgmt Studio, MongoDB, PostgreSQL, Kubernetes, RedHat OpenShift. + Desired Proficiency: R, Python, Rust, Swift. + Ability to perform tasks typically expected of a Data Engineer. **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The basic purpose of this role is to autonomously lead full stack Data Analytics software configurations for global and regional Data Analytics Product Groups. The Sr. Principal Solutions Engineer, Data Analytics is responsible for continuous design, development, configuration and maintenance of parameterized contextualization schemes relative to Manufacturing Science and Technology data science requirements. This role leads collaboration among global business stakeholders and site leadership teams; including Global IT, and Global Engineering. The incumbent will participate in the Advanced Analytics Strategy Forums to drive enterprise data management and systems architectural requirements. The primary expectation of this role is to be a world class expert in Data Analytics Computer Science. This includes proficiency in full stack data management supporting pharmaceutical and bio-pharmaceutical data sciences/advanced analytics. The incumbent is expected to work independently and coordinate global efforts on clean structured data acquisitions, data transformations, and data integration efforts required to enable statistical modeling, visualization, reporting, and interpretation of results. This role will coordinate the preparation of Quality Risk Assurance based data integrity and validation reports with appropriate business acumen for stakeholder interpretations and qualifications. The Sr. Principal Solutions Engineer, Data Analytics will manage junior level Data Engineers to provide analysis-ready batch contextualized vector and attribute data to statisticians and data scientists for applications of generalized linear modeling, time-series multivariate statistics including Principal Components Analysis and Partial Least Squares, QC test method validations, ANOVA/means comparisons, and univariate and multivariate Statistical Process Control (SPC) methodologies. This position is expected to collaborate and represent Data Analytics best practices to promote a broad Analytical Engineering ecosystem that delivers financial business value. This role will identify and implement new commercial and open-source software technologies that support more effective and efficient data science user experiences across multiple sites and programs. Duties & Responsibilities Sr. Principal Solutions Engineer, Data Analytics Executes the duties of data management and software configurations for complex pharmaceutical batch analytics. Maintains a high level of business acumen and data science knowledge to ensure the fit, form, and function of data science software. Collaborates with Data Analytics management, team, and stakeholders, to set and achieve project goals. Assumes departmental responsibility for multiple projects; capable of working independently to deliver objectives in a timely manner and capable of compiling industry standard reports suitable for internal compliance and/or regulatory submission. For projects of diverse complexity, provides architectural configuration support for all process historians, ERP, LIMS, and Electronic Batch Systems. Identifies and implements new commercial and open-source software technologies that support more effective and efficient data science user experiences across multiple sites and programs. Conducts periodic review of LAN, WAN, Edge servers in regional data centers and software architectures relative to data transfer rates and create data flow latency summarizations to ensure optimum user experiences for data scientists and local users. Continuously ensures agile software and data management effectiveness to support standard and advanced data science programs and product groups. Receives feedback and adjusts program management effectiveness from Global MSAT, Strategic site stakeholders and leadership, IT Governance bodies, and Global Engineering. Clearly communicates all aspects of data management requirements and functionality relative to Advanced Analytics outcomes to a diverse group of global stakeholders at all levels and locations of the organization. Maintains cutting edge industrial knowledge including a demonstrated ability to interpret and adapt primary literature, trade forums, and user meetings evaluating and when profitable, adapting new/emerging technologies to ongoing projects to enhance Data Analytics Product Groups. Principal Solutions Engineer, Data Analytics Executes the duties of data management and software configurations for complex pharmaceutical batch analytics. Responsible for maintaining a general level of business acumen and data science knowledge to ensure the fit, form, and function of data science software. Collaborates with Global MSAT Data Analytics management, team, and stakeholders, to set and achieve project goals. For projects of diverse complexity, provides configuration support for all process historians, ERP, LIMS, and Electronic Batch Systems. Helps perform feasibility studies for commercial and open-source software technologies identified by team leadership with the intent of more effective and efficient data science user experiences across multiple sites and programs. Conducts periodic review of LAN, WAN, Edge servers in regional data centers and software architectures relative to data transfer rates and create data flow latency summarizations to ensure optimum user experiences for data scientists and local users. Participates in agile software and data management standards to support advanced data science programs and product groups. Receives feedback and adjusts program management effectiveness from Global MSAT, Strategic site stakeholders and leadership, IT Governance bodies, and Global Engineering. Clearly communicates all aspects of data management requirements and functionality relative to Advanced Analytics outcomes to a diverse group of global stakeholders at all levels and locations of the organization. Requirements Sr. Principal Solutions Engineer, Data Analytics Bachelor's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field. In addition to bachelor's degree, a minimum of ten (10) years' experience supporting pharmaceutical or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. OR Master's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field and a minimum of seven (7) years supporting pharmaceutical and/or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. OR PhD in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field and a minimum of four (4) years supporting pharmaceutical and/or bio-pharmaceutical data sciences/advanced analytics within a regulated environment or similar organization. Required programming proficiency: C#, SQL, Graph, GO, Javascript, NoSQL. Required software experience: OSIsoft PI, PI AF, Libre, ETL Data Warehouse Design and Implementation, Grafana, SIMCA, SIMCA-online, SAS JMP, Visual Studio, MS DB Mgmnt Studio, MongoDB, PostgreSQL, Kubernetes, RedHat OpenShift. Desired Proficiency: R, Python, Rust, Swift. Demonstrated experience pro-actively identifying/detecting design issues and recommending solutions in global architectures and database design and implementations supporting global networks. Leadership experience managing others to successful outcomes with earned value. Demonstrated ability to: Perform tasks typically expected of a Data Engineer. Convey analytical thinking as well as business acumen and technical knowledge. Work effectively as part of a team and manage project(s) from a data management perspective. Determine appropriate database design, development, and configurations to deliver efficient architectural approach for advanced analytics. Principal Solutions Engineer, Data Analytics Bachelor's Degree in Computer Science, Information Science, Information Technology, Database Design and Implementation, or related field. In addition to relevant Bachelor's Degree, a minimum of seven (7) years applied computer science/data analytics experience in manufacturing industry, pharmaceutical, bio-pharmaceutical or related organization. OR Relevant Master's Degree and a minimum of four (4) years applied computer science/data analytics in manufacturing industry, pharmaceutical, bio-pharmaceutical or related organization. Academic and Demonstrated Knowledge of C#, SQL, Graph, GO, Javascript, NoSQL, Recommended software experience: OSIsoft PI, PI AF, Libre, ETL Data Warehouse Design and Implementation, Grafana, SIMCA, SIMCA-online, SAS JMP, Visual Studio, MS DB Mgmt Studio, MongoDB, PostgreSQL, Kubernetes, RedHat OpenShift. Desired Proficiency: R, Python, Rust, Swift. Ability to perform tasks typically expected of a Data Engineer. Desired Skills, Experience and Abilities

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 recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will collaborate with cross-functional teams, providing expertise in validating systems critical to the manufacture of life-changing products at the new site. The Senior Principal Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer is a key technical expert with partners to influence and implement within the Automation Engineering organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Key Objectives/Deliverables: • Technical Leadership • Mentor process control team, including design, controls philosophy, implementation and commissioning • Process control validation testing, implementation and coordination • Develop and implement the Automation Engineering Project Validation Plan. • Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: Process Automation Systems (DCS, SCADA, BMS, MES, Historian) Building Management System Vendor Packaged Equipment Data Historian Automated Storage and Retrieval System QMS • Perform risk assessments for computerized systems and develop strategies to mitigate identified risks • Develop and Execute validation protocols for computerized systems • Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity etc) and corporate Lilly quality policies and procedures • Generate and maintain validation documentation, such as validation plans and summary reports • Develop local site procedures (e.g SOPs, Work Instructions etc) related to automation systems • Manage change control and deviation management as it pertains to CSV activities • Collaborate with vendors to ensure that third party systems and software meet validation requirements. Conduct vendor audits as needed • Provide training to personnel on CSV principles, procedures and best practices • Stay informed of industry trends (e.g CSA) and advancements in CSV and automation technologies • Represent the automation department during audits by regulatory agencies as assigned • Act as functional owner for the Electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems Operational Excellence • Review and oversee the Design documentation including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications and execution. • Lead/Participate in design reviews and Automation application software reviews to ensure compliance and standardization. • Provide periodic status updates to Project Management • Devise CSV and quality strategies for control systems in collaboration with Site Quality organization • Implement and support electronic systems (such as plant historians) used to capture process automation related production data • Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation • Automation support for capital projects including new product introductions • Promote the use of automation to improve productivity, operational efficiency and compliance • Develop a ‘network' of corporate contacts and leveraging corporate expertise when needed Organizational Capability • In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. • Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. • Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement • Demonstrated ability to influence peers and business partners • Good written and verbal communication skills for both technical and non-technical audiences • Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: • Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling System integration of applications, systems and platforms and a minimum of 2 years working experience in Biopharma engineering, operations, or manufacturing. • Knowledge of GMP, regulatory requirements, computer system validation Additional Preferences: • For internal Lilly employees - LRL/Product Research Development experience preferred • Deep knowledge of GMP, regulatory requirements, computer system validation and data integrity • Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI). • Experience in commissioning, qualifying and supporting systems between SCADA, DCS, MES, LIMS, Historian and other applications for interconnectivity • Experience in design, development, commissioning and qualification activities ensuring quality compliance and data integrity. • Experience in facilitating and driving decision-making at an organizational level. Other Information: Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future. The Senior Principal Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer as a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Responsibilities Key Objectives/Deliverables: Technical Leadership Work with process control team, including project execution, budgeting, Agile methodology, implementation, commissioning Process control work implementation and coordination Develop and implement the Automation Engineering Project Plan and manage the Automation Engineering Portfolio. Operational Excellence Lead/Support the project management for the construction and commissioning of the Foundry site Work with the Automation Leadership for Project implementation, from tech transfer to design through validation and production launch. Track facility construction activities, coordinating with contractors, architects, engineers, and internal stakeholders. Serve as a liaison between construction teams, manufacturing operations, engineering, and regulatory affairs to ensure alignment and timely decision-making. Develop and manage detailed project timelines, budgets, and resource allocations; proactively identify and mitigate risks. Ensure all facility design and construction activities adhere to Good Manufacturing Practices (GMP) and regulatory requirements for radiopharmaceutical production. Manage internal and external project teams, providing clear direction, accountability, and communication. Prepare and deliver regular updates and presentations to the Automation Engineering Leadership, Foundry Leadership, Cross Functional Teams and external partners as required. Support the planning and facilitate the transition from construction to operational readiness, including facility qualification, equipment validation, and staff training. Implement project management tools and best practices for tracking progress, reporting, and documentation. Support and maintain the validated state of the site control systems in line with Lilly quality standards during the development and execution of validation strategies and associated documentation Automation support for capital projects including new product introductions Promoting the use of automation to improve productivity, operational efficiency and compliance Developing a ‘network' of corporate contacts and leveraging corporate expertise when needed Foster a culture of safety and compliance, ensuring all personnel follow HSE protocols Organizational Capability In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement Demonstrated ability to influence peers and business partners Good written and verbal communication skills for both technical and non-technical audiences Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: Minimum B.S. in Engineering with a minimum of 8+ years working experience in Biopharma engineering, operations, or manufacturing. Experience in Project Management preferably in the field of Automation Engineering, in major pharmaceutical companies and in Manufacturing Operations with extensive System integration of applications, systems and platforms Additional Preferences: Experience in leading commissioning, qualifying and supporting systems between SCADA, DCS, MES, LIMS, Historian and other applications for interconnectivity Experience in implementing Project Management and Portfolio tools for optimization. Experience in managing assets in CMMS particularly budgets, PO's, contracts and portfolio Experience in implementing Agile Methodology, Scrum and Kanban Experience in facilitating and driving decision-making at an organizational level. Experience in Project Management during Tech Transfer, design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, Site Historian systems, middleware applications (DeltaV, Rockwell, Building Management Systems, MES, LIMS, OSI PI, OPC). Other Information: Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $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 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. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will collaborate with cross-functional teams, providing expertise in validating systems critical to the manufacture of life-changing products at the new site. The Senior Principal Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer is a key technical expert with partners to influence and implement within the Automation Engineering organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Key Objectives/Deliverables: * Technical Leadership * Mentor process control team, including design, controls philosophy, implementation and commissioning * Process control validation testing, implementation and coordination * Develop and implement the Automation Engineering Project Validation Plan. * Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: * Process Automation Systems (DCS, SCADA, BMS, MES, Historian) * Building Management System * Vendor Packaged Equipment * Data Historian * Automated Storage and Retrieval System * QMS * Perform risk assessments for computerized systems and develop strategies to mitigate identified risks * Develop and Execute validation protocols for computerized systems * Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity etc) and corporate Lilly quality policies and procedures * Generate and maintain validation documentation, such as validation plans and summary reports * Develop local site procedures (e.g SOPs, Work Instructions etc) related to automation systems * Manage change control and deviation management as it pertains to CSV activities * Collaborate with vendors to ensure that third party systems and software meet validation requirements. Conduct vendor audits as needed * Provide training to personnel on CSV principles, procedures and best practices * Stay informed of industry trends (e.g CSA) and advancements in CSV and automation technologies * Represent the automation department during audits by regulatory agencies as assigned * Act as functional owner for the Electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems Operational Excellence * Review and oversee the Design documentation including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications and execution. * Lead/Participate in design reviews and Automation application software reviews to ensure compliance and standardization. * Provide periodic status updates to Project Management * Devise CSV and quality strategies for control systems in collaboration with Site Quality organization * Implement and support electronic systems (such as plant historians) used to capture process automation related production data * Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation * Automation support for capital projects including new product introductions * Promote the use of automation to improve productivity, operational efficiency and compliance * Develop a 'network' of corporate contacts and leveraging corporate expertise when needed Organizational Capability * In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. * Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. * Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement * Demonstrated ability to influence peers and business partners * Good written and verbal communication skills for both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: * Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling System integration of applications, systems and platforms and a minimum of 2 years working experience in Biopharma engineering, operations, or manufacturing. * Knowledge of GMP, regulatory requirements, computer system validation Additional Preferences: * For internal Lilly employees - LRL/Product Research Development experience preferred * Deep knowledge of GMP, regulatory requirements, computer system validation and data integrity * Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI). * Experience in commissioning, qualifying and supporting systems between SCADA, DCS, MES, LIMS, Historian and other applications for interconnectivity * Experience in design, development, commissioning and qualification activities ensuring quality compliance and data integrity. * Experience in facilitating and driving decision-making at an organizational level. Other Information: * Initial location at Lilly Technology Center, Indianapolis. * Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future. The Senior Principal Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer as a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Responsibilities Key Objectives/Deliverables: * Technical Leadership * Work with process control team, including project execution, budgeting, Agile methodology, implementation, commissioning * Process control work implementation and coordination * Develop and implement the Automation Engineering Project Plan and manage the Automation Engineering Portfolio. Operational Excellence * Lead/Support the project management for the construction and commissioning of the Foundry site * Work with the Automation Leadership for Project implementation, from tech transfer to design through validation and production launch. * Track facility construction activities, coordinating with contractors, architects, engineers, and internal stakeholders. * Serve as a liaison between construction teams, manufacturing operations, engineering, and regulatory affairs to ensure alignment and timely decision-making. * Develop and manage detailed project timelines, budgets, and resource allocations; proactively identify and mitigate risks. * Ensure all facility design and construction activities adhere to Good Manufacturing Practices (GMP) and regulatory requirements for radiopharmaceutical production. * Manage internal and external project teams, providing clear direction, accountability, and communication. * Prepare and deliver regular updates and presentations to the Automation Engineering Leadership, Foundry Leadership, Cross Functional Teams and external partners as required. * Support the planning and facilitate the transition from construction to operational readiness, including facility qualification, equipment validation, and staff training. * Implement project management tools and best practices for tracking progress, reporting, and documentation. * Support and maintain the validated state of the site control systems in line with Lilly quality standards during the development and execution of validation strategies and associated documentation * Automation support for capital projects including new product introductions * Promoting the use of automation to improve productivity, operational efficiency and compliance * Developing a 'network' of corporate contacts and leveraging corporate expertise when needed * Foster a culture of safety and compliance, ensuring all personnel follow HSE protocols Organizational Capability * In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. * Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. * Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement * Demonstrated ability to influence peers and business partners * Good written and verbal communication skills for both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: * Minimum B.S. in Engineering with a minimum of 8+ years working experience in Biopharma engineering, operations, or manufacturing. * Experience in Project Management preferably in the field of Automation Engineering, in major pharmaceutical companies and in Manufacturing Operations with extensive System integration of applications, systems and platforms Additional Preferences: * Experience in leading commissioning, qualifying and supporting systems between SCADA, DCS, MES, LIMS, Historian and other applications for interconnectivity * Experience in implementing Project Management and Portfolio tools for optimization. * Experience in managing assets in CMMS particularly budgets, PO's, contracts and portfolio * Experience in implementing Agile Methodology, Scrum and Kanban * Experience in facilitating and driving decision-making at an organizational level. * Experience in Project Management during Tech Transfer, design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, Site Historian systems, middleware applications (DeltaV, Rockwell, Building Management Systems, MES, LIMS, OSI PI, OPC). Other Information: * Initial location at Lilly Technology Center, Indianapolis. * Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future. The Senior Principal Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer as a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Key Objectives/Deliverables: * Technical Leadership * Mentor process control team, including design, controls philosophy, implementation and commissioning * Process control work implementation and coordination * Develop and implement the Automation Engineering Project Plan. Operational Excellence * Technically lead and oversee the work of Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications. * Lead/Participate in design reviews and DeltaV application software reviews, attend equipment and software FATs * Lead a team of automation engineers supporting commissioning * Provide periodic status updates to Project Management * Devising functional requirements and process control strategies for control systems in collaboration with Process Engineering * DCS software design, coding/configuration and testing (sequence logic, graphics, batch software etc.) * Automation Engineering including design, tuning and troubleshooting of control loops * Implementing and supporting electronic systems (such as plant historians) used to capture process automation related production data * Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation * Automation support for capital projects including new product introductions * Promoting the use of automation to improve productivity, operational efficiency and compliance * Developing a 'network' of corporate contacts and leveraging corporate expertise when needed Organizational Capability * In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. * Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. * Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement * Demonstrated ability to influence peers and business partners * Good written and verbal communication skills for both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: * Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling Laboratory and Analytical systems and equipment, and Systems Integration. * 8+ years working experience in Biopharma engineering, operations, or manufacturing. * Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI). * Experience in commissioning, qualifying and supporting Analytical equipment such as cell counters, environmental testing, filter testing, etc. * Experience in facilitating and driving decision-making at an organizational level. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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 Engineering Tech Center is responsible for providing global technical expertise in the engineering sciences related to Process Engineering and secondary/tertiary loop disciplines. This includes knowledge and stewardship of the following: First Principles, unit operations, Equipment Flow Diagrams, Capability Calculations, Material & Energy Balances, Facilities (fitness for use), Root Cause applications, Equipment and Unit Operation Changes/Improvements including new technologies, Scale-ups, Periodic Reviews, Process Safety, Maintenance/Reliability, etc. This function has a global presence. This team provides engineering support to global manufacturing sites for the customer network, Global Facilities Delivery (GFD), development sites, as well as external manufacturing organizations and alliances. This Visual Inspection Engineering position serves as a technical expert/resource in Parenteral Technologies for the inspection of semi-finished products globally and will be focused on the evaluation, delivery, implementation and support of automated, semi-automated and manual inspection equipment. Parenteral sites supported include Indy Parenteral (IPM), Fegersheim, Sesto, Suzhou, Research Triangle Park (RTP), Concord and Alzey. This position also applies technical knowledge to effectively guide and support Lilly's partner companies and contract manufacturers. Key Objectives/Deliverables Technical and Discipline leadership -Partners with other technical staff to direct discipline activities, oversight of the community, new technology development and technology assessments, creation and maintenance of Engineering Standards, Master specifications and Best Practices for the discipline, and coaching and mentorship of junior engineering staff. Safety and Compliance - Ensure personal and team compliance with all applicable regulatory and corporate policy requirements; ensure appropriate safety practices and procedures are in place and are followed to prevent injuries; ensures the ETC meets current Quality expectations and is a part of actively monitoring evolving Quality and other regulatory expectations related to engineering Consultation - Assists sites globally with technical evaluations, master planning, technology assessments, and specific problem resolution including troubleshooting and root cause analysis Knowledge sharing - Provides ongoing technical support to site engineering groups, domestic and global. Serves as a mentor to Lilly engineers with a focus on technical development and functional capability building. Interfaces with and develops site technical experts in Parenteral Engineering. Reviews and prepares protocols and technical reports. External Influence - Monitors and, when appropriate, influences change in external codes and standards on Lilly's behalf. Ensures external learnings are effectively communicated within Lilly and works to ensure ongoing compliance with these learnings. Major Capital Support - Provides technical consulting and leadership, both conceptual and detailed design, to Global Facilities Delivery on major capital projects. Will often lead multi-functional/multi-site project teams. External Manufacturing Support - Provides technical consulting and leadership to Lilly's external manufacturing partners. Responsibilities will be range from due diligence, tech transfer, engineering batches to deviation investigation support. Will work closely with cross-functional projects teams managing the relationships with our partners Platform Owner - Provides Network technical leadership, oversight, and ownership for designated equipment platforms or processes. Influences platform alignment across the Network to maximize project delivery, operational and maintenance efficiencies, and replicated cost benefits. Develops strong relationships with our Original Equipment Manufacturers (QEMs) and leverages these partnerships as we develop new designs, trouble-shoot equipment issues and maintain our equipment. Innovation - Investigates, develops, and integrates emerging technology and capabilities applicable to the Parenteral manufacturing process to meet production and compliance requirements. Deliverables include input and support of facility design, equipment layout, technical specifications, vision system and equipment optimization, inspection testing and qualification. Basic Qualifications Bachelor's degree in engineering or related technical field. 5-15+ years' experience in cGMP manufacturing or manufacturing support Extensive knowledge of parenteral equipment (5+ years) and operations including automated, semi-automated and/or manual inspection equipment. Additional Skills/Preferences: Familiarity with technology advances in vial, cartridge, and syringe container closure systems. Strong interpersonal and communication skills to be effective in a team-based environment. Ability to work across boundaries (functional, geographic, external company, etc.) Demonstrated learning agility Ability to work effectively with outside suppliers. Demonstrated ability to solve technical problems and implement projects. Other Considerations Business title is subject to change depending on level Must be able to travel up to 35% of the time with potential for more, US and international. High potential for short term assignments (1-6 months) at Lilly or partner sites may be required Will require occasional work in a variety of manufacturing environments; some safety equipment and/or gowning 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 $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. 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

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care, and as such will become a part of the BD organization in the future. Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com Provides expertise in the optimization of product development. How you will make an impact: Design and develop components and systems utilizing SolidWorks design tools while applying mechanical engineering principals. Lead in the improvement, design and optimization of more complex experiments, tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work. Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components and subsystems Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications Create/update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements Develop project plans to assess technology and drive project results Train, coach, and guide lower-level employees on more complex procedures What you'll need (Required): Bachelor's Degree in Mechanical Engineering with a minimum of 8 years' experience including either industry or industry/education or Master's Degree or equivalent in in Engineering or Scientific field with a minimum of 6 years' experience, including either industry or industry/education Required or What else we look for (Preferred): Experience with Ansys and or Icepak FEA tools Excellent documentation and communication skills Excellent interpersonal relationship skills including negotiating and relationship management skills Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering Advanced problem-solving, organizational, analytical and critical thinking skills Extensive understanding of processes and equipment used in assigned work Ability to influence others Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts Represents organization in providing solutions to difficult technical issues associated with specific projects Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Irvine Laguna CanyonAdditional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $124,700.00 - $205,800.00 USD Annual

SummaryAssociate Staff Engineer - SustainingJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Associate Staff Engineer - Sustaining Summary: The Associate Staff Sustaining Engineer will support new product development and sustaining engineering activities of vascular access devices in all stages of the product life cycle. This includes supporting design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post-market surveillance. The candidate will be responsible for ensuring products are safe and effective by developing test methods, executing device evaluations, interpreting data results, authoring technical documents, and presenting findings to management. In addition, the individual will be responsible for communicating requirements to suppliers and managing external resources to meet project milestones on time and within budget. The ideal candidate should have experience in medical device industry or related field. Knowledge of FDA regulations, IEC standards, ISO 10993, and quality system requirements such as MDSAP would be beneficial. Experience with design control process, risk analysis, and conducting human factors studies is required. Responsibilities: Supports all phases of new product development and sustaining engineering activities including design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post-market surveillance Develops/update user documentation (e.g., specifications, protocols, reports) according to applicable FDA regulations, IEC standards, ISO 10993, and quality system requirements. Manages external resources to ensure timely completion of projects. Communicates requirements to suppliers and ensures they are met. Works closely with multi-functional teams to execute project plans. Performs activities in compliance with SOPs and other quality systems requirements. Participates in audits and inspections as needed. Applies fundamental knowledge of engineering fundamentals. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships. Reports to Manager, Sustaining Engineering. Qualifications: Bachelor's degree in Engineering or Science discipline plus minimum of 8 years relevant experience OR Master's degree in Engineering or Science discipline plus 6 years relevant experience. Medical device industry experience preferred. Ability to understand complex business processes and develop efficient solutions. Strong communication skills (written and verbal). Ability to travel domestically and internationally approximately 5% of time. Proficient computer skills (Microsoft Office Suite). Demonstrated ability to handle multiple competing priorities simultaneously while meeting deadlines. Ability to interpret data, draw reasonable conclusions, and make sound decisions based upon available information. Familiarity with Design Control Process and Risk Analysis. Working knowledge of FDA regulations (21 CFR Part 820), IEC Standards (60601 series), ISO Standards (14971, 13485, 10993), and quality system requirements (MDSAP). At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA UT - Salt Lake City BASAdditional LocationsWork Shift

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. BD is searching for a Staff Systems Engineer to join our rapidly expanding Pharmacy Automation Systems Engineering team. System Engineers are characterized by their disciplined, quantitative approach to system and technology integration as well as diverse cross-functional backgrounds and general knowledge of related disciplines. These individuals deploy tools and processes such as Design for Six Sigma and product development processes (waterfall, Agile) within a quality management system to enable more predictable product development and high quality products. System Engineers are responsible for technology integration in systems that have both enterprise software and electromechanical (hardware / embedded software) components. The Systems Engineer is a key member of the team and will contribute to system-level definition, design, and testing for robotic systems through close collaboration with hardware design, software, and other functional groups. Main responsibilities will include: Ownership of Systems Engineering inputs and outputs for teams supporting innovation, new product development, or product lifecycle management. Responsibility for development and maintenance of system/product design architecture and system/product requirements. Document system/product-level requirements and manage changes via team review, approval, and release processes. Lead the definition and documentation of system interfaces and interface requirements. Ensure design traceability from user needs through requirements to test evidence and support the use of appropriate software tools for the creation and maintenance of the trace matrices. Lead system/product-level integration, bug/defect tracking and configuration management. Lead the system evaluation process through development and execution of system level test plans and protocols including data analysis, interpretation and communication of results and their impact through written reports, design reviews, and interactive discussions. Lead system verification and validation activities for a multi-functional project team including protocol writing, execution and reporting. Contribute to the transition from R&D to manufacturing/service and support resolving system issues for products in the field. Liaise between R&D and other functions to inform/support teams based on quality procedures including risk analysis and verification/validation for specific subsystems. Education and Experience Must have a bachelor's degree in science or engineering (5+ years of experience in technical area). A postgraduate degree is preferred. Background in electro/mechanical devices and/or automation A strong technical background and experience within Systems Engineering - Requirements Management, Hazards Analysis, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Reliability Engineering, and Failure Modes Effects Analysis. Proven track record developing complex experiments independently, performing statistical analysis, interpreting experimental results, and making informed recommendations. Apply creative problem-solving skills to novel or complex applications. Ability to self-direct and manage own work Ability to collaborate in multi-disciplinary team settings, influence decision making, and build group consensus. Strong problem-solving and debugging skills and an interest in learning new technologies. Excellent written and oral communication skills Experience implementing and educating others in Design for Six Sigma (DFSS) methodologies is a bonus. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA NC - Durham - Roche DriveAdditional LocationsWork Shift

Senior Power Electronics Engineer Who we are… We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that make our company a community where we make a life, not just a living. Who you are… You love details and precision. You find enjoyment in solving puzzles, designing and mapping systems, and building efficient circuitry. Words that describe you are focused, curious, and collaborative. What you can expect to work on… The Power Electronics Engineer role at Niowave has responsibility over design, implantation and integration of accelerator power systems. These systems are varied and include critical accelerator subsystems like the cathode heater, the electron gun tuners, etc. This position will also involve support to cryogenics, RF, and high voltage subsystems and some involvement in circuits that enable or control specialized accelerator systems like RF and beam loss detectors. Design, implement and maintain accelerator power systems including controlled heaters and tuners. Consult with controls engineers on the proper power layout for normal-conducting beamline magnets and beamline diagnostics. Interface with nuclear engineers concerning the design and operation of the x-ray conversion target. Be part of the team designing the concept, architecture, and components of future systems. Conduct optimization work on existing systems, perform measurements and validation tests Confirm system capabilities by designing testing methods What you need to succeed… Bachelor's degree in the fields of electrical engineering, specifically power electronics and circuits 5+ years of power electronics experience. Experience designing, building and testing systems. Broad understanding of power electronics/circuitry technology. Regularly engages in mentoring multiple team members in all aspects of RF Engineering. Expert level analytical and problem-solving skills; Organizational and project management skills for self and teams. Embrace and model the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understand how to integrate into a new team/organization - appreciate the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understand their own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two. Great to have… Master's or Doctorate degree in the fields of electrical engineering, power electronics, circuits, etc. 8+ years of power electronics related experience. 5+ or more years of experience with power electronics and accelerators in a research or production environment. Experience leading teams to complete large projects. 2+ years' experience of direct supervisory experience of five or more people. Work Environment… Full-time position. The company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M - F with an expectation of adjusting to meet technical objectives and to meet with staff working outside of the standards operating hours as needed. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. Please provide a cover letter specifically describing the nature of your technical expertise.

SummaryGIE - EDE Staff EngineerJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. GIE EDE Staff Engineer Summary: This position is responsible for Assembly Design and Process Implementation across the Medical Segment business and is positioned to ensure that the company's component design, supply, cost, etc. are aligned to business expectations. This position provides expert engineering skill, judgement, and mentoring of other engineers. This role will oversee the planning, coordination and oversight in the development and implementation of assembly and packaging equipment and related activities as well as support new product development. This role will establish and maintain strong technical relationships at external vendors. Develops Strategies, Collaborates and Communicates with: * Product Design Team: to ensure product is designed to enable a mfg. process which can produce product efficiently (target COGS) and to required quality standards. * Unit Quality Team: to ensure that equip. is designed/manufactured in compliance with regulatory requirements/industry standards. * Production Team: to ensure that equipment is designed for efficient production, and to support mfg. process. * Maintenance/Engineering Team: to ensure max. equip. uptime, and that equip. is designed for easy maintenance/repair * Procurement & Vendors: to ensure that components meet standards/safety and can be sourced timely/cost-effective. * Plant Quality Team: to ensure that equip. is operating within specified tolerances and products meet required quality & regulatory standards. * Production Team: to ensure that equipment is operating efficiently/effectively to meet production targets. * Plant Maintenance Team: to ensure that equipment is maintained and serviced according to recommended schedules and procedures. * Program Management Team: to ensure that project meets specified requirements that equipment is delivered on time within budget. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Scope: Medical segment operations manufacturing process technology across all manufacturing sites & all products. Build competitive advantage for the Medical segment business through the leverage of manufacturing process technology. Projects responsibilities and field of action are focus in developing equipment for Medical segment. This includes URS creation, equipment design, FAT execution and support SAT completion and approval, including vendor selection and PO. Managing one or several projects to perform and lead to success the above-described tasks. RESPONSIBILITIES Process Development (Quality, Efficiency and Harmonization): Responsible for the design of assembly and packaging equipment, responsible for user requirements specifications (URS) to ensure it meets specific manufacturing requirements. Provide cost input (equipment, engineering, materials) into CB-2. Manage the integration of new equipment through SAT completion, and support Equipment Integration during install and startup. Implement Process Design on new equipment and ensure product designs are being met. Provide feedback and validate that the equipment design meets safety and operational standards based on experience and validation from respective stakeholders. Leads suppliers and external design teams (vendor) for larger capital projects to manage cost, lead time and scope. Partnerships with procurement for vendor selection. Active participant with suppliers regarding process optimizations and continuous improvements on automations projects Captures process performance from sites, existing assembly lines Responsible for vendor contracts in collaboration with procurement and legal . Develop innovative concepts for mechanical systems and equipment based on project requirements, industry trends, and standard methodologies. Create, or obtain from the vendor, detailed 3D models/2D drawings of mechanical components and assemblies using CAD software. Create and maintain design documentation, including user requirement specifications, assembly instructions, bill of process, etc. Optimize equipment designs to minimize production costs and changeover time, simplify assembly processes, design from the operator's standpoint, maintainability, and ensure manufacturability. Participate in design reviews, risk assessments, and continue to build failure mode and effects analysis (FMEA) to ensure reliability, safety, performance of mechanical systems/equipment. Collaborates with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary. Perform various engineering analyses / simulation (i.e. stress, strain, thermal, fluid dynamics) to validate and optimize design. Work closely with other engineering fields. (i.e. electrical/mechanical engineers) to ensure seamless integration of mechanical systems with other project components. Support operations during a production crisis. (quality, supplier, etc.) Comply with all local, state, federal, and BD safety regulations, policies, and procedures. Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles. Other duties as assigned. Leading KPI Cost of production & OEE. Percentage of project completed on time , in scope and to budget. Lagging KPI Reliability Overall Equipment Effectiveness Number of process failures experienced. EXPERIENCE/EDUCATION Minimum Education: Bachelor's Degree in Mechanical Engineering, Electrical Engineering or related field Minimum Experience: 5+ years in assembly equipment design / procurement is required Tooling design experience of assembly processes is desired Proficiency in SolidWorks is desired Excellent technical skills including project management, organization, planning, and capital budgets relating to equipment procurement and verification. Demonstrated ability to apply problem solving and data analysis methods. Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired. Experience in an FDA regulated quality environment desired. Willingness and ability to travel domestically and internationally up to 40%. Experience leading projects end to end. Strong communication skills Risk analysis / FMEA Statistical analysis / SPC system Ability to manage multiple conflicting priorities, and to develop and maintain tool qualification schedules. Physical requirement: Ability to use a laptop/computer for extended periods of time (up to 8 hours) Ability to sit for long periods of time (up to 8 hours) in virtual and/or on-site meetings Ability to stand for long periods of time (up to 8 hours) when conducting FAT, SAT, on-site equipment/process troubleshooting, etc. Ability to climb steps, squat, etc. Ability to work independently in High Volume manufacturing floor Follow Safety and Quality/GMP requirements for medical device manufacturing site (Safety shoes, safety glasses, hair net, beard net, face mask, hard hat, etc….as required per manufacturing site) Main contacts to do the job: Internal Reasons GIE other Teams Plant LT and manufacturing teams BU functions: Quality, SC, Customer facing, R&D teams External Reasons Vendors, Customers, Consultants, procurement, Quality WW R&D project teams Machine vendors Supervision (if applicable): N/A For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Management Level JG 4 (P4) At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA NE - Columbus (West) Additional LocationsWork Shift