associate director - automation engineering – control system hw, technology and site support - lilly

associate director, ts/ms manufacturing cmc project management

field service engineer - automation industry

associate director - automation engineering – control system hw, technology and site support - lilly Jobs in Indianapolis

associate director - launch leader Jobs in Indianapolis

associate director - launch leader

associate director, ts/ms manufacturing cmc project management Jobs in Indianapolis

field service engineer - automation industry Jobs in Indianapolis

general superintendent - systems Jobs in Indianapolis

general superintendent - systems

associate director automation engineering control system hw technology and site support lilly

Information Technology Senior Management Forum

<div><div>Posted Date
4/28/2026
</div><div>Description
<div>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&rsquo;re looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.
Organization and Position Overview
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 Associate Director-Automation Engineering - Control System HW, Technology and Site Support is responsible for the supervision of the Automation Hardware, I&amp;C, Site support function that support the daily operations of the facility and managing the overall Automation technology support. The Associate Director is also responsible for the productivity and development 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 Associate Director 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), leadership roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.
Responsibilities:
Key Objectives/Deliverables:
<ul><li>Administrative Leadership</li></ul>
<ul><li>Supervise and lead the Hardware, I&amp;C and Automation site support team, including completing performance reviews and development plans.</li></ul>
<ul><li>Responsible for the Automation Technology management to deliver Automation team milestones and projects.</li></ul>
<ul><li>Staffing, including recruiting, resource planning, and succession planning.</li></ul>
<ul><li>Process validation work coordination.</li></ul>
<ul><li>Review and monitor financial performance; commit to meeting targets</li></ul>
<ul><li>Actively participate and support the Automation Engineering Operations and Training Program</li></ul>
<ul><li>Develop Project, Program and Initiatives execution metrics with analytics team.</li></ul>
Operational Excellence
<ul><li>Demonstrate a commitment to environmental, health, and safety</li></ul>
<ul><li>Identify, track, and report key indicators of functional performance</li></ul>
<ul><li>Ensure team is operating in a state of compliance</li></ul>
Organizational Capability
<ul><li>In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.</li></ul>
<ul><li>Assure focus by engineers and completion of critical assignments with appropriate monitoring and reporting</li></ul>
<ul><li>Ability to instill teamwork within the department and demonstrate key interpersonal skills.</li></ul>
<ul><li>Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.</li></ul>
<ul><li>Ability to make decisions independently and to network with others as appropriate.</li></ul>
<ul><li>Ability to function in a team environment as a leader and as a member of management teams.</li></ul>
Basic Requirements:
<ul><li>Minimum B.S. in Engineering and ten years' experience in Site Support, Hardware Instrumentation, Project and Portfolio management, preferably in pharmaceutical manufacturing</li></ul>
<ul><li>Experience in leading major projects from design, development, commissioning to qualification.</li></ul>
Additional Preferences:
<ul><li>Experience in design, development, commissioning and qualification of control and network panels, loop checks, IQ in a highly automated greenfield manufacturing site.</li></ul>
<ul><li>Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, QMS, Site Historian systems (DeltaV, Rockwell, Syncade, Veeva, OSI PI,).</li></ul>
<ul><li>Experience in developing and implementing an operational site support structure for day-to-day operations in a running plant.</li></ul>
<ul><li>Experience as a member of the group leadership in running the plant, including participation in management sub-teams.</li></ul>
<ul><li>Successful application of organizational models through recruiting and retention of employees.</li></ul>
Other Information:
<ul><li>Initial location at Parkwood West, Indianapolis, Indiana.</li>
<li>Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.</li>
</ul>
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $180,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>
</div><div>Salary
123,000.00 - 180,400.00 Annual</div></div><div></div>

Associate Director - Automation Engineering – Control System HW, Technology and Site Support - Lilly

Eli Lilly

<div>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&rsquo;re looking for people who are determined to make life better for people around the world.
The Automation Engineer &ndash; OSI PI and Data Integration will enable information and data flow between Manufacturing Science, Quality, Engineering, Supply Chain, and Operations by leveraging IT and Process Automation Technologies. This role will support innovation evaluation and application for Manufacturing Process Automation and IT Systems with a focus on data historians (OSI PI), OT data integration, advanced analytics, data integrity, and process optimization. The primary focus of the role will be to work with our Process Automation and IT systems to integrate data supporting a number of key corporate initiatives. These systems include (but not limited to) process automation platforms, HMI/SCADA, Data Historians (OSI PI), and Manufacturing Execution Systems (MES)
Key Objectives/Deliverables 
Lead design, development, and deployment of technical and application solutions to meet business requirements across an IT/Automation portfolio that are cost effective and sustainable
Serve as the frontline support for all PI and LogMate end users (700+ users) with responsibility to create action plans and strategies to resolve performance issues 
Manage routine health checks on all PI infrastructure components, including PI Data Archive servers, PI AF servers, PI Vision servers/displays, PI Interfaces and PI Connectors, and LogMate servers and collectors. Make recommendations on how to maintain high performance levels on all systems 
Perform emergency response to system notifications (email and SMS), including configuration of alerting rules on mobile devices and respond to critical alerts after hours and weekends as needed. Make recommendations on process solutions.
Provide subject matter expertise on OSI PI Data Historian platform for automation engineering
Data Integration &ndash;Develop robust and innovative solutions enabling our manufacturing engineers to utilize data to drive improvement decisions, identify issues, and utilize advanced analytics.
Drive implementation and use of technology governance processes.<div>
Incident Response and Service Management (ServiceNOW) 
<ul><li>Coordinate with platform teams including Windows, Network, CyberArk, InfoSec, and others during escalations.</li></ul></div><div>
PI Tag Governance and Configuration Management 
<ul><li>Execute and manage all PI Tag Lifecycle activities including creation, modification, retirement, documentation, naming standard compliance, engineering units, scaling, and point attributes.</li></ul></div><div>
Patch, Reboot, and Certificate Coordination 
<ul><li>Coordinate patching and reboots for more than 40 PI and LogMate servers, including scheduling and monitoring return-to-service.</li><li>Manage server certificate renewals and installations using Venafi workflows.</li></ul></div><div>
Change Control and Quality Compliance 
<ul><li>Draft change controls for PI and LogMate systems in TrackWise.</li><li>Execute or support Data Management team change steps.</li><li>Ensure all automation and historian system changes include proper impact assessments.</li></ul></div><div>
DeltaV Integration Support 
<ul><li>Coordinate and monitor DeltaV patching events affecting PI and LogMate data sources.</li><li>Verify successful return of DeltaV interfaces after reboot or patch activities.</li></ul></div><div>
Service Account and Password Management 
<ul><li>Manage PI and LogMate service accounts using CyberArk, including password rotations, secure credential storage, new account requests through ServiceNOW, and safe access governance.</li><li>Ensure compliance with audit and security requirements for privileged accounts.</li></ul></div><div>
Vendor Engagement and External Support 
<ul><li>Open and track Aveva PI and TiPS LogMate support cases.</li><li>Participate in troubleshooting sessions for complex system issues.</li></ul></div><div>
User Support, Training, and Communications 
<ul><li>Serve as the primary communicator for PI and LogMate-related updates, outages, alerts, and changes.</li><li>Provide training to engineers, operators, data consumers, and new employees.</li></ul></div><div>
Documentation and Governance 
<ul><li>Maintain and update CSV-based documentation packages.</li><li>Support audit trail review activities.</li></ul></div>
Basic Requirements:
<ul><li>Manufacturing experience.</li><li>Bachelor&rsquo;s degree in electrical, mechanical, Chemical or computer engineering</li></ul>
Additional Preferences:<ul><li>
Engineering experience would be valuable.</li><li>
Expereince with Delta V</li><li>
Experience in a food and beverage or chemical manufacturing area.</li><li>
Ability to prioritize and handle multiple tasks and requests.</li><li>
Ability to effectively communicate with and coordinate activities of small groups.</li><li>
Experience in process manufacturing (e.g. operations, maintenance, utilities).</li><li>
Basic computer skills and proficiency with Excel, Word, MS Project.</li><li>
Ability to learn other computer systems (e.g. CAPA)</li><li>
Able to work in a team environment.</li></ul>
Education Requirements:<ul><li>
Bachelor&rsquo;s degree in electrical, mechanical, Chemical or computer engineering</li></ul>
Other Information:<ul><li>
This position serves an 8-hour Monday through Friday work schedule. Situations may arise where off-schedule work, both on-site and off-site, will be required.</li><li>
This position requires 24/7 availability with a cellphone.</li><li>
Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.</li></ul>
The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision 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 (https://careers.lilly.com/us/en/workplace-accommodation) 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&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $149,600
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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>

Automation Engineer-OSI PI and Data Integration

<div>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&rsquo;re looking for people who are determined to make life better for people around the world.
Organization Overview:
The Associate Director &ndash; Launch Leader will participate in the development and implementation of manufacturing strategies, capacity management projects, and launch of new products for the Indy Device Assembly and Packaging (IDAP) site. The Associate Director &ndash; Launch Leader will represent IDAP in discussions with external groups (e.g. corporate supply chain, other network sites, sales and marketing affiliates, etc.) through various forums and meetings to support development of Site and Network plans. The Associate Director &ndash; Launch Leader will also be required to lead or participate in special projects in support of the Site and Logistics Department. 
Responsibilities:<ul><li>
Develop and propose manufacturing strategies related to Parenteral, Dry or Device products</li><li>
Manage site product portfolios: capture and pursue business opportunities / challenges</li><li>
Influence and provide support for Site Business and Long-Range Plans</li><li>
Support Site and Global S &amp; OP processes</li><li>
Introduction and deletion of products and pack changes</li><li>
Outsourcing or product deletion management</li><li>
Serve as the site SME for supply chain projects and support enhancements to Supply capabilities</li><li>
Assist in special projects or improvement opportunities as identified</li><li>
Support Commercialization Projects within IDAP and IPM</li></ul> 
Basic Requirements:<ul><li>
Bachelor's degree or equivalent work experience.</li><li>
Demonstrated Project Management skills.</li><li>
Experience with SAP.</li><li>
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.</li></ul> 
Additional Skills/Preferences:<ul><li>
Preference for candidate with Parenteral Products, Dry Products, or Device experience</li><li>
Ability to communicate and influence effectively across functional groups</li><li>
Strategic thinking and capability</li><li>
Capability to prioritize and multi-task effectively</li></ul>
Additional Information:<ul><li>
Travel 0-5 %</li><li>
Shift information - Day shift, but flexible to meet with global affiliates during off hours due to time zone differences.</li><li>
Position location - Indianapolis - LTC-S</li></ul>
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$127,500 - $187,000
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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>

Associate Director - Launch Leader

<div>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&rsquo;re looking for people who are determined to make life better for people around the world.
Purpose:
The purpose of the Associate Director / Director, Global Medicines Quality Organization (GMQO) (M2/M2-2) role is to maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s). This position provides strategic input, focuses on results, thinks critically, and emphasizes team collaboration to the achievement of goals and objectives.
This position leads GMQO associates responsible for supporting the execution and delivery of submissions to global health authorities. To achieve this goal, the role uses their technical expertise and a strong working knowledge of internal procedures and external GCP regulations/expectations. This position is responsible for leadership and resource management, quality system implementation, audit and inspection readiness, quality project management and process improvement.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Primary Responsibilities:
Leadership and Resource Management<ul><li>
Accountable for the recruitment, development, and retention of a diverse and highly capable workforce</li><li>
Responsible for ensuring individual training plans and timely completion of required training for direct reports.</li><li>
Responsible for talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making</li><li>
Ensure GMQO associate competencies are present and continuously improving</li><li>
Manage workload based on portfolio prioritization, regional requirements and individual level of expertise, and address implications to overall resource management and strategies</li><li>
Drives a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered</li><li>
Responsible for coaching and mentoring staff in the areas of work procedures, the Safety and Efficacy Quality System (SEQS), and issue resolution</li><li>
Lead by example through credible technical coaching</li></ul> 
Quality System Implementation<ul><li>
Support, define and/or facilitate quality reviews, quality consultations, deviation and change management, quality planning, CAPA implementation, quality assessments, quality issue resolution within area of responsibility</li><li>
Ensure quality assessments are conducted to monitor the quality of clinical development within the business area</li><li>
Monitor and report metrics to business management</li><li>
Evaluate and effectively partner with the business on quality initiatives</li><li>
Represent Lilly both internally and externally in the area of clinical development, regulatory or safety quality</li></ul>
Audits and Inspections<ul><li>
Facilitate and/or deliver audits, regulatory inspections, and regulatory responses</li><li>
Ensure ongoing inspection readiness of area</li><li>
Escalate issues that will significantly impact clinical development activities, portfolio delivery, and business priorities, and recommend necessary follow-up actions</li></ul>
Project Management and Process Improvement<ul><li>
Identify and/or drive projects for the development and implementation of the SEQS</li><li>
Support and/or lead global process improvement initiatives</li><li>
Share learning and ensure communication to share best practice within business area and across the Global Medicines Quality Organization</li></ul>
Minimum Qualification Requirements:<ul><li>
Bachelor&rsquo;s Degree, preferably in a health-related or scientific field</li><li>
Experience in clinical development
</li><li>Demonstrated strong knowledge of GCP guidelines and regulations within the area of responsibility</li><li>
Supervisory experience</li><li>
Experience working in a global environment</li><li>
Strong leadership and self-management skills</li><li>
Strong verbal and written communication skills</li><li>
Demonstrated problem solving and critical thinking skills</li></ul>
Other Information/Additional Preferences:<ul><li><h3 class="jobSectionHeader">
Demonstrated project management experience.</h3></li></ul>
This is an Indianapolis-based position with at least 3 days per week on-site at Lilly Corporate Center.
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $180,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>

Associate Director / Director - Global Medicines Quality Organization

<div>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&rsquo;re looking for people who are determined to make life better for people around the world.
The Clinical eDC Study Build Programmer is responsible for programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization and testing.
This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.
Responsibilities:
Portfolio Delivery:<ul><li>
Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components</li><li>
Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives</li><li>
Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)</li><li>
Support submission, inspection and regulatory response activities</li><li>
Lead cross Business Unit/Therapeutic Area projects or programs with high complexity</li><li>
Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio</li></ul>
Project Management:<ul><li>
Increase speed, accuracy, and consistency in the development of systems solutions</li><li>
Enable metrics reporting of study development timelines and pre and postproduction changes to database</li><li>
Partner to deliver study database per business need and before first patient visit</li><li>
Follow and influence data standard decisions and strategies for a study and/or program</li><li>
Apply therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data</li><li>
Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables</li><li>
Integrates multi-functional and/or external information and applies technical knowledge to data-driven decision making</li></ul>
Enterprise Leadership:<ul><li>
Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis</li><li>
Represent Data and Analytics processes in multi-functional initiatives</li><li>
Actively engage in shared learning across the organization</li><li>
Work to Increase re-usability of forms and edits by improving the initial design</li><li>
Work to reduce postproduction changes change control process</li><li>
Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization</li><li>
Interacts with regulators, business partners and outside stakeholders on business issues</li><li>
Thinks with end to end in mind consistently managing risk to minimize impact on delivery</li><li>
Builds a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development</li><li>
Focuses on defining database solutions and timelines in support of advancing the portfolio</li></ul>
Other responsibilities<ul><li>
The experienced Clinical Study Build Programmer &ndash; eDC is expected to provide coaching and guidance for junior Clinical Study Build Programmers.</li><li>
The Clinical Study Build Programmer &ndash; eDC may or may not lead a team of junior Clinical Study Build Programmers. If in supervisory positions, the Clinical Study Build Programmer &ndash; eDC is expected to:</li><li>
Participate in the recruitment, development, and retention of a scientific, technical, and operationally capable workforce that is skilled and knowledgeable in end-to-end global clinical eDC system builds</li><li>
Provide effective technical leadership to an agile team of technical staff that continuously meets the needs of a changing portfolio and demonstrates judgment-based decision making, and provide leadership in clinical eDC system build delivery</li><li>
Creating a team culture that fosters inclusion and innovation and values diversity</li><li>
Responsible for effective resource planning</li><li>
Responsible for supervising clinical study build programmer staff, as assigned, including aspects of training, mentoring, goal setting, performance management, and engagement. Other activities include setting objectives, soliciting feedback from stakeholders, and conducting performance reviews to foster growth of staff.</li><li>
Ensure all necessary training is provided to staff to support job performance and knowledge. Help to remove any barriers or obstacles that impede them from achieving company, functional, and individual objectives.</li></ul>
Basic Qualifications:<ul><li>
Master&rsquo;s degree in a scientific or technical field such as Informatics/Analytics, Life Sciences, Information Technology, Computer Sciences (or bachelor&rsquo;s degree plus 5 or more years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors)</li><li>
At least 3 years of eDC Study Build Programming experience</li><li>
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position</li></ul>
Additional Preferences:<ul><li>
Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.</li><li>
Knowledge of industry standard clinical technologies including CTMS, EDC (Veeva CDMS preferred, Rave, InForm), eCOA, IxRS, Clinical Data Repositories, etc.</li><li>
Knowledge of CDISC and CDASH standards/standard terminology</li><li>
The ability to work independently as well as in a team environment.</li><li>
Project and Vendor management experience</li><li>
Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.</li><li>
Demonstrated ability to stay abreast of trends and new information in the profession.</li><li>
Quick learner to new trends in technology</li><li>
Excellent leadership, communication (written and oral) and interpersonal skills</li><li>
Demonstrated teamwork and collaboration in a professional setting</li></ul>
Experience with the following:<ul><li>
Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions</li><li>
Deciding the technology platform (system/database) for data acquisition and aggregation</li><li>
Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)</li><li>
Strong therapeutic/scientific knowledge in the field of research</li><li>
Society of Clinical Data Management certification</li><li>
Project management experience</li><li>
Familiarity with clinical data tools and technologies</li><li>
Understanding and experience in using data standards</li><li>
Ability to balance multiple activities, prioritize and manage ambiguity</li><li>
Demonstrated exemplary teamwork/interpersonal skills</li><li>
Proven problem solving, attention to detail and result oriented behaviors in a fast-paced environment.</li></ul>
Other Information:<ul><li>
Domestic and International travel may be required</li></ul>
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$79,500 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>

Clinical eDC Study Build Programmer

<div>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&rsquo;re looking for people who are determined to make life better for people around the world.
Position Brand Description:
This role is responsible for integrating Manufacturing CMC elements to support molecule commercialization and to manage the development and implementation of an integrated technical plan for commercially manufactured molecules. This position leads a cross functional team to ensure integrated and innovative CMC plans which accelerate life changing medicines to patients throughout the Manufacturing Life Cycle with safety first and quality always. The role is also responsible for coordinating the Global Product Assessment (GPA) for the molecule(s) which they support. A person in this position would have a CM&amp;C focus, be expected to apply Project Management principles, provide decision-making leadership for a cross functional team, and participate in process improvement activities within Manufacturing.
Key Objectives/Deliverables
Team Leadership<ul><li>
Responsible for leading a Development and Manufacturing (central and site) team of moderate to high complexity and scope through development and execution of project plans that deliver strategic and operational objectives.
</li><li>Support the Development CM&amp;C teams in developing strategies and implementing operational plans to deliver required materials (such as API, drug product formulations, registration stability lots, clinical trial materials, etc.) as needed to support a particular project.
</li><li>Influence Development Manufacturing Technical Agenda and pre submission deliverables to enable effective transition to downstream Manufacturing plan/deliverables.</li><li>
Develop and manage an integrated Post Launch Technical Agenda for assigned molecules to support launch/commercial needs, reliable supply and productivity objectives.</li><li>
Responsible for the integration of the team plan to achieve Life Cycle Management objectives.</li></ul>
Project Management Leadership<ul><li>
Responsible for delivery of project milestones on time and within scope through the utilization of project management approaches and tools.
</li><li>Document key team information and decisions and ensure project management systems are up to date.</li><li>
Encourage appropriate risk taking within the team by leading risk assessments and contingency planning at the team level.</li><li>
Resolve team issues with Manufacturing priorities in mind.</li><li>
Ensure strategic alignment with key stakeholders.</li><li>
Support upward and cross-functional communications.</li><li>
Actively track leading indicators of teams&rsquo; progress to major milestones.</li><li>
Build and maintain effective teams: motivate, recognize, coach &amp; mentor team members and associates.</li><li>
Gain and share learning and optimized practices within and across teams.</li></ul>
Governance Facilitation and Reporting<ul><li>
Responsible for facilitating Manufacturing Reviews and other governance alignment
</li><li>Ensure reporting of project status, metrics, and risk. Escalate as necessary.
</li><li>Coordinate Global Product Assessments (GPAs), with Technical Stewards and Manufacturing sites, to ensure holistic review of control and capability of the manufacturing processes.</li></ul>
Functional Leadership<ul><li>
Mentorship of peers and team members
</li><li>Support process improvement</li><li>
Subject Matter Expert of a process or system</li></ul>
Basic Requirements:<ul><li>
Minimum 5 to 10 years&rsquo; experience in more than one Pharmaceutical Development CM&amp;C function OR Pharmaceutical Manufacturing function/site</li><li>
Demonstrated leadership of cross-functional teams</li><li>
Demonstrated project management experience</li><li>
Demonstrated knowledge of CM&amp;C aspects of Commercialization and Commercial Manufacturing</li><li>
Strong interpersonal and teamwork skills</li><li>
Strong oral and written communication skills</li><li>
Strong problem-solving skills, self-management and organizational skills.</li><li>
BSc Required. MSc in Chemistry, Biology, Engineering, Project Management, or MBA preferred.</li></ul>
Additional Preferences:<ul><li>
Demonstrated knowledge of CM&amp;C aspects of Pharmaceutical Drug Development</li><li>
Experience in Technical Services/Manufacturing Services, Manufacturing Operations, and/or QA/QC within Pharmaceutical Manufacturing highly desirable.</li><li>
Experience with Smartsheet as a Project Management tool.</li><li>
Master&rsquo;s in project management, PMP Certification, or MBA preferred.</li></ul>
Other Information:
<ul><li>Some travel (domestic and international) may be required. Less than 5%</li></ul>
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$117,000 - $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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>

Associate Director, TS/MS Manufacturing CMC Project Management

Inotiv

<div>The Quality Control &amp; Continuous Improvement Specialist plays a critical role in ensuring product and process quality at Inotiv&rsquo;s operational sites. This on-site role combines hands-on quality control testing, scientific analyses, and process optimization with support for continuous improvement initiatives, risk mitigation, and operational efficiency. Reporting to the Associate Director, the specialist helps implement quality and CI strategies across multiple operational areas, supports root cause investigations, drives process improvements, and ensures compliance with regulatory and internal standards. This position fosters a culture of accountability, operational excellence, and continuous improvement, while contributing to cross-functional collaboration and the overall success of Inotiv&rsquo;s QC and CI programs. 
Key Responsibilities:
Quality Control &amp; Product Testing<ul><li>
Perform scientific analyses of raw materials, in-process materials, and finished products to ensure compliance with established quality standards.</li><li>
Select and test products according to defined QC protocols and specifications.</li><li>
Document, interpret, and analyze QC data to identify trends, deviations, and opportunities for process improvement.</li></ul>
Problem Solving &amp; Process Improvement<ul><li>
Take proactive ownership of problem identification, resolution, and risk mitigation.</li><li>
Conduct root cause investigations and assist in designing and implementing corrective and preventive actions (CAPAs).</li><li>
Use Lean, 5S, Six Sigma, process mapping, and other continuous improvement tools to optimize workflows, prevent defects, and improve efficiency.</li><li>
Develop and implement novel systems or tools to enhance quality and process reliability.</li></ul>
Operational Support &amp; Collaboration<ul><li>
Work collaboratively with QA, Operations, Veterinarians, Facilities &amp; Maintenance, and other stakeholders to troubleshoot and resolve production or process issues.</li><li>
Participate in process development, optimization, and implementation across animal, feed, enrichment, laboratory, and operational functions.</li><li>
Support other operational functions as trained and qualified.</li></ul>
Documentation &amp; Compliance<ul><li>
Maintain accurate QC records, SOPs, work instructions, quality records, and other documentation in alignment with regulatory and internal standards.</li><li>
Ensure data integrity, audit readiness, and adherence to AAALAC, IACUC, USDA, CDC, and other relevant regulatory requirements.</li><li>
Provide on-site support for internal, customer, and regulatory audits.</li></ul>
Continuous Improvement &amp; Team Support<ul><li>
Participate in continuous improvement initiatives, including 5S activities, FMEAs, Gemba walks, and other operational excellence programs.</li><li>
Help drive a culture of continuous improvement and operational excellence by leading by example.</li><li>
Provide guidance, mentoring, and training to junior QC staff, supporting their professional development.</li></ul>
On-Site Presence &amp; Additional Duties<ul><li>
Full-time on-site presence is required.</li><li>
Perform additional duties as assigned to support QC and CI objectives.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree in Life Sciences, Engineering, or related field.</li><li>
Knowledge of NC/RCI/CAPA processes, audits, and regulatory compliance.</li><li>
Experience with Lean, Six Sigma, 5S, FMEA, process mapping, and statistical data analysis preferred.</li><li>
Strong analytical, problem-solving, and communication skills.</li><li>
Ability to work collaboratively in a fast-paced, cross-functional environment.</li></ul><ul><li> 
This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person&rsquo;s relevant experience and/or education level.</li></ul>
Inotiv is a growing contemporary drug discovery and development company where we &ldquo;Play to Win&rdquo; in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There&rsquo;s an opportunity for everyone at all phases of a career, each individual&rsquo;s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people&rsquo;s lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.
Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!
Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.</div>

Quality Control and Continuous Improvement Specialist I

Explore 423+ Associate director automation engineering control system hw technology and site support lilly in Indianapolis this May. Find roles across top companies and apply now to boost your career.