Engineering

Eli Lilly and Company

Sr. Advisor - Global Technical Services Molecule Steward - Dry Products

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.

**We are seeking talent at the Sr. Principal Scientist through Sr. Advisor level; the final title and scope will be aligned with the candidate’s experience, organizational impact, and leadership capabilities.**

**Key Objectives/Deliverables**

- Serve as Manufacturing TS/MS (Technical Services/Manufacturing Science) representative to integrate the commercialization work plans across Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new solid oral dosage forms.
- Leverage prior commercial manufacturing and development experience of solid oral dosage forms to anticipate commercial manufacturing challenges for new oral products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs.
- Ensure that experiments and technical work plans are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement or advanced application of control strategies across sites and technologies.
- Serve as the Global Molecule Steward for select solid oral dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
- Achieve network level results for Lilly's dry products (solid oral dosage forms) that improve the effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business. Influence global leadership to drive improvements and resolve issues.
- Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across manufacturing sites according to best practices and technical principles.
- Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies.
- Leverage prior experience and knowledge as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms including continuous manufacturing. Influence Development strategies for new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of new technologies as appropriate.
- Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed.
- Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes.
- Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions.
- Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.

**Basic Requirements:**

- BS, MS, and/or PhD in Chemistry, Engineering, Pharmaceutical Science, or related science.
- Minimum 7-10 years of direct experience in **Oral Solid Dose Form Manufacturing and Development/Commercialization.**
- A minimum of 3 years of commercial manufacturing support (post process validation) of solid oral dosage forms with ability to apply this experience to development of new solid oral dosage form products.
- Evidence of technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization, and commercial GMP manufacturing.

**Preferred Qualifications:**

- Demonstrated, strong analytical and problem-solving abilities. Effective at integrating multiple technology disciplines to drive programs forward.
- Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions.
- Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines.

**Additional Preferences:**

- Flexibility to travel and interact with multiple partners/functions, regions, and cultures.
- Ability to lead cross functional teams effectively. Ability to work independently, and within teams. Provides partnership and collaboration across multiple disciplines.
- Demonstrated, strong analytical and problem-solving abilities.
- Effective at integrating multiple technology disciplines to drive programs forward.

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](<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’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’s education, experience, skills, and geographic location. The anticipated wage for this position is

$117,000 - $209,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Associate VP for Dry Products/Spray Dried Dispersions

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

As the Associate VP for Dry Products/SDD, you will provide scientific and organizational leadership for one of the fastest growing portions of Eli Lilly & Co’s portfolio. You will ensure the organization provides the technical product stewardship through hiring, developing, and retaining strong talent with the right technical capabilities. Success will require strong collaboration and partnership with key stakeholders such as Product Development, Manufacturing sites, Network scientific resources, and other functional areas to ensure alignment and prioritization of the organization’s key deliverables and technical agenda.

**Key Responsibilities/Deliverables:**

**Build and run the organization**

- Determine the appropriate technical expertise that should exist at a Network level, and work to close capability gaps through hiring, development, and retention of technical talent.

- Ensure that resources are deployed effectively to deliver timely and rigorous support to the dry product sites.

- Oversee the performance management process for the organization and ensure all employees have development plans in place to elevate performance and support career goals.

- Conduct interim and end of year performance reviews

- Coach, develop, and provide feedback to reports

- Lead recognition, compensation, and promotion activities

- Lead talent assessment and succession planning for network and site TS/MS organizations

- Encourage shared learning within and outside the department

- Lead short and long-term business planning (objectives, budget, capital, capability)

**Lead control strategy, commercialization, and tech agenda**

- Work with leadership of TS/MS, PR&D, Quality, Engineering, and Operations to develop the expectations for Control Strategy Implementation.

- Work with PR&D to ensure that control strategies for new products are robust.

- Actively work with Dry product sites to install processes with robust validations.

- Develop a strong working relationship with Development to support new products commercialization.

- Ensure

- Build and scale up/pilot plant capability vital to support the network tech agenda through the development of technical talent, pilot plant infrastructure/capital, and ensuring all individuals have adequate training.

**Ensure TS/MS** **Functional Excellence at Manufacturing Sites**.

- Ensure that we build functionally excellent TS/MS groups at each manufacturing site within the network.

- Coach and mentor the TS/MS heads at the Dry products manufacturing sites.

- Ensure that there are appropriately trained individuals, adequate recruiting, and adequate succession planning at the sites.

- Become the point of contact for critical manufacturing issues and ensure appropriate escalation of significant issues. Consult on deviations, process changes, and validations.

**Foster a culture of safety & 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;

- Ensure that Dry products/SDD meets current Quality expectations and is a part of actively monitoring evolving Quality and other regulatory expectations related to dry products manufacturing.

**Basic Qualifications:**

- BS in pharmaceutical sciences, pharmacy, engineering, Chemistry, or a related field. Masters or PHD preferred

- 15+ years experience in Pharmaceutical Manufacturing, Technical Services, Product development with a minimum of 4 years previous supervisory experience.

**Additional Skills/ Preferences:**

- Understanding of cGMPs in a manufacturing setting.

- Outstanding written and oral communication skills.

- Knowledge of corporate policies.

- Ability to influence without direct authority.

- Experience in technical leadership positions in Dry Product manufacturing

- Strong leadership and written and oral communication skills

- Effective interpersonal skills

- Demonstrated problem solving abilities.

- Recognized as knowledgeable on oral solid dosage form and dry product technologies

- Effective at integrating multiple technology disciplines to drive programs forward.

- Partnership and collaboration across multiple disciplines

**Additional Information:**

**Environmental and Working Conditions (Personal Considerations)**

- Occasional access to manufacturing/processing areas where there may be gases, noise, dust, chemicals, solvents, grease, inflammables, and machine in movement.

**Tools, Machines, Equipment, Materials**

- Occasionally may use personal protection equipment such as safety shoes, laboratory coats, gloves, hardhat, and any other equipment as needed.

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](<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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$241,500 - $354,200

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

Utilities / Medium Voltage Electrician / Instrumentation

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

**Position Brand Description:**

The Utilities / High Voltage Electrician / Instrumentation has the responsibility of servicing, troubleshooting, and maintaining equipment in LTC utilities that includes instrumentation, electrical, high purity water, compressed air, steam, chilled water, glycol, city water, and sewers. They are expected to display good customer service skills and to ensure that utility equipment and buildings are maintained at all utility locations. The Utilities / High Voltage Electrician / Instrumentation is expected to assist craftspeople in multiple crafts.

**Key Objectives/Deliverables:**

- Perform preventative and corrective maintenance on high and low voltage electrical equipment (13.8KV main switch gear, circuit breakers, relays, motor starters, ground fault interrupts)
- Perform preventive maintenance on complex electrical equipment (motor control centers, variable-speed drives, programmable logic controllers, etc.)
- Troubleshoot and diagnose electrical equipment problems and make appropriate repairs to minimize downtime.
- Perform modifications and new installations of electrical equipment (e.g., conduit, conductors, lighting, branch circuits, etc.).
- Diagnose complex electrical problems to effect repairs and restore equipment/systems to operating condition.
- Perform preventative/corrective maintenance and calibration on process instrumentation (temperature, pressure, flow, pH, conductivity, TOC, control valves, etc.)
- Troubleshoot and diagnose process instrumentation equipment and make appropriate repairs to minimize downtime.
- Perform modifications and new installations of process instrumentation.
- Demonstrate the ability to read P&ID drawings and schematics.
- Consistently comply with safety rules and closely follow approved procedures to ensure cGMP compliance.
- Document all work by following Good Documentation Practices.

**Basic Requirements:**

- Strong electrical and mechanical aptitude.
- Must possess basic instrumentation/electrical skills as well as the ability to troubleshoot basic electrical circuits and equipment.
- 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.
- Must be able to withstand exposure to temperature variations while performing work outside in winter and summer weather conditions.
- Must be capable of lifting 40 lbs.

**Additional Skills/Preferences:**

- Associate degree in Electronics Technology, electrical license, or equivalent instrumentation/electrical work experience.
- Experience working with 4160V (4.16kV) electrical systems preferred.
- Experience with utility systems – HPW, chillers, steam, compressed air, water/sewer, electrical distribution.
- Experience troubleshooting and new installation of various instrumentations.
- Experience maintaining circuit breakers, relays, medium voltage switchgear, motor starters.
- Experience with a CMMS (e.g., GMARS), or similar work order tracking system.
- Document work using good documentation practices.
- Proficiency in basic use of Microsoft Office tools (e.g., Word, Excel).

**Education Requirements:**

- High School diploma, associate degree or equivalent.

**Additional Information:**

- Hazardous operations exist in utility areas, involving the use of caustic, steam, high pressures, and high temperature.
- Work Schedule: 8-hour days, Monday through Friday, requires off-hours support for equipment operating 24/7.
- This position requires working on summer and year-end company breaks
- Awkward positions, cramped quarters, ladders, and scaffolding work will be required at times.
- This position requires the completion of a Post Offer exam

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](<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’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’s education, experience, skills, and geographic location. The anticipated wage for this position is

$21.27 - $41.25

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Engineering Associate Director (AD) - Device Assembly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Overview:**

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 billion to create a new state-of-the-art manufacturing site, in Kenosha, Wisconsin. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Kenosha County site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

**Position Brand Description:**

The Engineering Associate Director (AD)- Device Assembly is responsible for the staffing, training, and leadership of the engineering group (both process, automation and maintenance) supporting asset delivery, process development, commissioning, qualification, validation and startup of the packaging lines in the site expansion project. After startup, the Engineering AD will be responsible for supporting the day-to-day engineering activities as well as planning for the 3 - 6-month horizon. The Engineering AD is expected to lead by example and provide coaching to others in the areas of safety, quality, engineering, optimization and continuous improvement.

**Key Objectives/Deliverables:**

**Manage for Results /Strategic Planning:**

- Manage Engineering and Maintenance support for Commercial Manufacturing Operations:
- Manage team of process and automation engineers and maintenance technicians providing Front Line support in one or more of the following areas:
- Parenteral Operations (Parts Washers, Autoclaves, Formulation, Isolator – Syringe Filler, Automated Visual Inspection)
- Device Assembly
- Packaging Operations
- Warehouse and Logistics (Autonomous Guided Vehicles, Automatic Storage and Retrieval System, etc.)
- Site Utilities (HVAC, Steam Water, Gases, etc.), BMS, Chambers (i.e. Refrigerators, Incubators, Cold Rooms, etc.)
- Ensure appropriate technical and maintenance support for manufacturing or utilities processes of the assigned area.
- Guide SMEs that will provide coaching/assistance to Front Line Engineers and drive increased equipment reliability and uptime, continuous improvements, support capital delivery, among other key strategic initiatives.
- Understand, ensure and decision making based on engineering standards and policies, procedures and business plan that impact the ability of the team members to meet performance objectives.
- Provide Functional Leadership to engineering and maintenance representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
- Lead, support and peer review root cause analysis around equipment and operational events, support complex change controls and quality investigations with strong Root Cause analysis focus.
- Prioritize teams work to optimize equipment output and impact, ensuring proactive and continuous improvement mindset for process and operational improvements and optimization.
- Apply statistical thinking and data analysis methods to understand process variability and capability to drive improvements.
- Support regulatory inspections.
- Utilize control systems to monitor, trend and verify equipment performance and downtime. Identify and Optimize unit operation cycle time, yield performance, loop tuning, recipes, etc.
- Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem-solving techniques are appropriately utilized. On call/off hours support required.
- Understand and ensure compliance with environment health & safety requirements.
- Present and attend various Governance teams to represent engineering.
- Represent group as technical SMEs on capital projects supporting/leading design, modifications, testing, qualifications, and associated documentation.
- Support commissioning and qualification activities.

**Leadership**

- This position involves direct management of front-line & SME engineering and maintenance team members.
- Provide leadership, training, development, coaching and support of engineering team members.
- Engage and promote use of internal and external networks and partnerships to help deliver sound technical decisions.
- Promote use of first principals with engineering staff and drive engineering solutions for problems.
- Monitor and ensure compliance with quality requirements. (trainings, CAPA, deviations)

**Basic Requirements:**

- Bachelor's degree in engineering
- At least 7 years process engineering experience

**Additional Preferences:**

- Previous management or leadership experience including leading or working effectively with a cross functional group
- Strong experience in equipment optimization, reliability and troubleshooting
- Strong technical aptitude and ability to train and mentor others
- Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
- Previous experience with highly automated equipment.
- Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment.
- Previous facility or area start up experience.
- Previous equipment qualification and process validation experience.
- Previous experience with Manufacturing Execution Systems and electronic batch release.
- Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
- Previous experience with deviation and change management systems including Trackwise.

**Other Information:**

- Up to 20% travel and more can be expected during the startup phase.
- Required to be on call, as applicable.
- Shift work may apply.

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](<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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$123,000 - $198,000

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

Wisconsin

Senior Program C&Q Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Facilities Delivery (GFD) Organization, part of Manufacturing & Quality, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of project management, engineering, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

The Senior Program C&Q Lead owns commissioning and qualification (C&Q) for an assigned capital program or site – setting the C&Q strategy, driving field execution, and delivering systems that are validated, GMP-compliant, and ready for reliable startup and handover to Site Operations. This is a senior individual contributor role: the Senior Program C&Q Lead is Lilly's technical owner and single point of accountability for C&Q on the program.

**Key Responsibilities**

**C&Q Strategy, Planning & Scheduling**

- Create, own, and implement the C&Q strategy, plans, and schedules for the assigned program, aligned to Lilly's CQV standards and to the relevant manufacturing platform and network requirements (API, LAPI, PDN, LMF).
- Define system boundaries, system classification, and the commissioning and qualification scope and turnover package structure so testing is executed once, at the right level of rigor, with no gaps or duplication.
- Build and maintain the integrated C&Q schedule, including critical path analysis, 2–4 week look-aheads, and resource loading; integrate C&Q sequencing with construction, automation, and startup milestones.
- Forecast C&Q resource demand and partner with program leadership and service providers to secure the right contingent and contract resources at the right time.

**C&Q Execution & Field Coordination**

- Direct day-to-day C&Q execution in the field through C&Q firms and contingent C&Q node leads; ensure adherence to C&Q procedures and program strategy in all activities.
- Review and accept mechanical completion (MC) turnover from construction management and C&Q firms, and drive closeout of punch list items with C&Q firms and SWAT teams.
- Coordinate pre-commissioning activities including utility priming, instrument calibration, automation downloads, installation of consumables (e.g., filter cartridges), and VFD setup.
- Coordinate across nodes and with site utilities on demand for temporary power and utilities (e.g., steam, water) and on wastewater discharge and loading of drains and sumps.
- Partner with the mechanical and construction teams on lock-out/tag-out (LOTO) and the transition of systems from construction control to commissioning control.

**Factory Acceptance Testing (FAT)**

- Plan and lead FAT for the program – defining test strategy, reviewing and approving protocols, setting schedules, and coordinating with vendors, engineering, and construction so equipment and systems are verified ahead of shipment and startup.
- Witness FAT at vendor sites, disposition findings and deviations, and confirm resolution before release to site.

**Qualification, Documentation & Handover**

- Author, review, and approve commissioning and qualification protocols, test scripts, deviations, and summary reports; ensure right-first-time execution and audit-ready records.
- Ensure structured capture and turnover of engineering and asset information through Project Information Management (PIM) – specifications, drawings, test records, as-builts, and handover data packages – so assets transition to Operations complete and audit-ready.
- Lead or support system handover to the User team and Site Operations, including punch resolution, training support, and documentation turnover.

**Quality, Compliance & Safety**

- Ensure C&Q activities meet regulatory, corporate, and site quality requirements; partner with Quality and support inspection readiness for the program.
- Manage C&Q change and deviation processes, including impact assessment against the approved scope and escalation of compliance risk.
- Enforce a strong safety culture by ensuring all commissioning and qualification activities comply with site safety standards and industry best practices, promoting a safe working environment for all team members.

**Technical Expertise & Continuous Improvement**

- Serve as the program's C&Q subject matter expert, providing technical direction and coaching to contract and contingent C&Q resources without a direct reporting relationship.
- Continuously identify opportunities to improve C&Q practices across the program, driving efficiency while maintaining compliance.
- Feed lessons learned back into GFD CQV standards, methods, and templates so improvements are captured for future programs.

**Reporting & Governance**

- Report progress, risks, and issues directly to program leadership and the Senior Director, Asset Delivery, providing clear visibility into C&Q status, quality, and compliance risk.
- Report program C&Q metrics including change management against initial scope, progress and performance measurement, 2–4 week look-aheads, critical path analysis, and resourcing.

**General**

- Collaborate across detailed design, project engineering, construction, automation, Quality, Site Operations, and program teams; take on priorities as they emerge.

**Qualifications Required**

- Bachelor's in Engineering, Life Sciences, or a related field.
- 15+ years of commissioning, qualification, and validation (CQV) experience in GMP-regulated environments, including leading C&Q execution on capital projects.
- Demonstrated hands-on experience across the validation lifecycle – commissioning, qualification, systems turnover, startup support, and handover to operations.
- Experience planning and executing Factory Acceptance Testing (FAT) with equipment vendors.
- Ability to travel, both within and outside the US as required, approximately 35% expected; site-based program assignments may require extended field deployment.
- 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.

**Preferred**

- Experience directing C&Q contractors and service providers and coordinating field execution alongside construction teams in an active construction environment.
- Proven ability to influence and deliver results without direct authority in a complex, matrixed, contractor-leveraged organization.
- Experience delivering C&Q on greenfield and/or GMP-regulated pharmaceutical or life-sciences facilities.
- Experience on mega capital expansion projects ($100 million+ in total installed cost).
- Experience with CQV in API, LAPI, sterile / parenteral, and/or biologics facilities.
- Master's degree in engineering, science, or a related field.
- Professional credentials such as ISPE CPIP, PE, or PMP.
- Familiarity with tools such as validation / commissioning platforms (e.g., Kneat), Oracle Unifier, Smartsheet, and Power BI.

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](<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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$159,000 - $233,200

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

Alabama

Senior Program Director - Huntsville - GFD

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

**Organization Overview:**

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Key Objectives/Deliverables:**

- Project Management: Lead and manage teams to deliver large programs of at least $1BN USD or more in capital assets that are highly business-critical in nature. These teams will consist of both Lilly and Non-Lilly professionals, working to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance.
- Interface/Communication: Ability to lead from a regional distance from corporate headquarters while developing and maintaining effective communication with GFD leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement project work safely with quality, speed, and value.
- Compliance: Lead with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.
- Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification.

**Minimum Requirements:**

- Bachelor of Science in Engineering or a technical related field (i.e. project management).
- Minimum of 15+ years previous experience in capital project delivery in industrial or manufacturing facilities (preferably leading projects/multiple projects \>$100MM in size).
- Previous experience managing greenfield projects.
- Willingness to relocate and/or travel to locations outside of home state/country.

**Additional Preferences:**

- Pharmaceutical manufacturing experience.
- Capital Project Management Experience in pharmaceutical manufacturing facilities such as: Bulk API, sterile products, secondary packaging, devices, and to a lesser extent, lab projects.
- Experience in the following areas: GMP manufacturing, LEAN, automation, construction, construction quality, project controls, the engineering disciplines, safety, and scheduling.
- The capacity to achieve results and influence through people.
- Demonstrated ability to work from long distances with little supervision.
- Must exhibit a good sense of judgment in decision making, without the need for management approval, while at the same time keeping management informed and engaged on critical issues.
- Effective communication skills, both written and verbal.
- Ability to influence personnel and organizations without having direct administrative responsibility for them.
- Competency in a foreign language(s).
- Professional Engineer (PE) or equivalent technical certification.
- Project Management Professional (PMP) certification.
- Experience in working and/or living outside the U.S.
- Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change.

**Additional Information:**

- International travel is likely in this role and may include weekends and multi-week stays (15% to 30% travel, domestic and international).
- The position will require full relocation to the project location at a later date, as it does require onsite presence.
- This requisition is part of an Ai Candidate Skills Matching Pilot, Candidates dispositioned as “RESUME NOT REVIEWED” have not been reviewed by a human, however AI has been used to prioritize candidates for review based on how closely their skillset matches up to the skills needed for the role.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<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’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’s education, experience, skills, and geographic location. The anticipated wage for this position is

$159,000 - $255,200

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

Syner-G BioPharma Group

Project Manager

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

Syner-G is seeking a Project Manager to oversee and manage construction and engineering projects from planning through commissioning and closeout. This role is responsible for coordinating project activities, maintaining schedules and budgets, and ensuring work is completed safely, efficiently, and in alignment with quality and regulatory expectations. The Project Manager will work closely with clients, contractors, engineering teams, and internal stakeholders to drive successful project execution.

**WORK LOCATION:**

Travel to client sites may be required up to 100%, based on project demands and client expectations.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented or adjusted as necessary.)

- Keep the Project Director informed of project progress, risks, and issues, and provide recommended solutions or mitigation strategies.
- Review technical submissions from Architectural and Engineering (A&E) firms, including MEP drawings, structural drawings, and construction specifications.
- Respond to and manage construction communications such as RFIs, submittals, and technical clarifications.
- Assist with preparation and execution of job start-up and close-out checklists.
- Read, interpret, and manage project plans, specifications, contracts, subcontracts, purchase orders, correspondence, shop drawings, and other project-related documents.
- Maintain accurate and complete as-built project documentation.
- Support Transfer of Care and Custody (TOCC) to facilities operations and ensure proper documentation for transition from construction to maintenance mode.
- Use project and construction management software such as ProCore, E-Builder, or Prolog.
- Act as the owner’s representative on capital projects, ensuring alignment with client expectations and project goals.
- Use Microsoft Project to develop, maintain, and track project schedules.
- Participate in daily planning meetings, document observations, and ensure alignment across project teams.
- Walk construction sites regularly to verify progress, identify field issues, and support resolution efforts.
- Prepare daily reports, photo documentation, and progress measurements.
- Review construction site safety documents such as work permits, task plans, and job hazard analyses, and collaborate with the client’s EHS team to ensure compliance.
- Coordinate and support contractors including general contractors, construction managers, mechanical, electrical, and specialty trades.
- Support project execution in active operating facilities, ensuring minimal disruption to ongoing operations.
- Assist with start-up, commissioning, and handover of building systems including HVAC, emergency power, UPS systems, lab gases, RODI water, boilers, and steam generators.
- Develop and implement document control, information management, and records governance processes.
- Establish standards for filing structures, naming conventions, metadata, version control, and quality assurance.
- Coordinate documentation requirements, deliverables, turnover strategies, and audit readiness across project teams.
- Monitor compliance, documentation quality, and drive continuous process improvement.
- Develop training materials, procedures, and best practices to ensure consistent adoption across the organization.

**QUALIFICATIONS AND REQUIREMENTS:**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

*Education:*

- Bachelor’s degree in Mechanical, Chemical, Electrical Engineering, Construction Management, or a related field preferred.
- PMP certification is a plus.

*Technical Experience:*

- 4–9 years of experience in project engineering or project management, preferably in industrial, chemical, petrochemical, biotech, or related environments.
- Experience supporting or managing capital projects from design through construction and commissioning.
- Experience coordinating contractors across multiple disciplines (GC, CM, mechanical, electrical, etc.).
- Experience executing projects within active operating facilities.
- Experience participating in commissioning and turnover of building systems such as HVAC, emergency power, UPS, lab gases, RODI water, boilers, and steam systems.
- Experience conducting site walks, identifying field issues, and supporting resolution efforts.
- Experience preparing daily reports, photo documentation, and progress tracking.
- Experience reviewing safety documentation and collaborating with EHS teams.

*Knowledge, Skills, and Abilities:*

- Strong communication skills with the ability to interface effectively with client stakeholders, managers, contractors, and subcontractors.
- Proficiency with Microsoft Project and familiarity with construction management software.
- Detail-oriented with strong analytical, organizational, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

**COMPENSATION:**

The expected salary range for this position is $120,000 to $130,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

California

MES Engineer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**MES Engineer**

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 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.

Lilly is investing $6.5 billion to build a new state-of-the-art active pharmaceutical ingredient (API) manufacturing site at Generation Park in Houston, Texas. The new site will produce APIs for small-molecule medicines for cardiometabolic health and will be built with the latest high-tech equipment, highly integrated and automated manufacturing systems, and a focus on minimizing environmental impact. This is a once-in-a-lifetime opportunity to help build and start up a new site.

**What You'll Be Doing**

The MES Engineer is part of the new API facility's MES team, supporting the design, development, delivery, and computer system validation of DeltaV MES solution. You will implement, configure, and support the MES solution to meet the site's operational, quality, and compliance needs — working closely with Operations, Tech Services, Engineering, Quality, and the broader Tech at Lilly team to ensure successful deployment and long-term support of MES capabilities.

**Your Primary Responsibilities**

- Partner with site teams to gather requirements, define digital workflows, and author/validate electronic batch records aligned with operational processes.
- Support MES startup activities, including configuration of MES recipes, workflows, electronic work instructions, and electronic batch records (EBRs).
- Configuration of electronic logbooks (Equipment Tracking) and Weigh & Dispense
- Configuration of MES interfaces with other manufacturing systems (ERP system, Historian, DCS, Manufacturing Equipment via Edge technology, etc)
- Implement and support site-level testing and validation efforts (e.g., Installation Qualification, Performance Qualification) to ensure system readiness.
- Generation of associated CSV (Computer System Validation) documentation
- Troubleshoot MES issues and collaborate with multi-functional teams to resolve system or process gaps.
- Support site readiness and go-live efforts, including hypercare support and frontline troubleshooting.
- Ensure compliance with Lilly Global Standard Operating Procedures (GSOPs) and Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5.
- Develop and maintain system documentation, SOPs, training materials, and support guides
- Collaborate with global/site MES architects and platform teams to align on standards, design, and configuration best practices.

**What You Should Bring**

- Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP)
- Experience with DeltaV MES (Previously known as Syncade) Recipe Authoring and validating Master Batch Records (MBRs) in a regulated environment.
- Strong analytical and problem-solving skills across applications, configurations, and integrations.
- Excellent communication skills, with the ability to articulate complex technical concepts to non-technical audiences.
- Ability to work closely with Operations, Quality, Engineering, and IT teams to translate operational needs into executable MES solutions.
- Experience with tier-one MES platforms, in particular Emerson Syncade/DeltaV.

**Your Basic Qualifications**

- Bachelor’s Degree in IT, Engineering, or related technical field,
- 5+ years experience with MES system design, implementation, and validation.
- 3+ years of experience in regulated pharmaceutical or medical device manufacturing environments.
- 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.

**Additional Preferences**

- Prior experience with no-code/low-code frontline platforms, in particular Tulip, and with distributed control systems such as Emerson DeltaV, including recipe and batch interfaces to MES.
- Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials.
- Professional experience working in a GxP regulated environment.
- Experience commissioning and qualifying systems at a new site, and supporting API, small molecule, oligonucleotide, or synthetic chemistry operations.

**Other Information**

- Role is based onsite at Houston, Texas – API Manufacturing Site

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](<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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $158,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Texas

Advisor - Program Manager - GFD

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Key Objectives/Deliverables:**

- Project Management: Lead and manage teams to deliver large programs of at least $500MM USD or more in capital assets that are highly business-critical in nature. These teams will consist of both Lilly and Non-Lilly professionals, working to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance.
- Interface/Communication: Ability to lead from a regional distance from corporate headquarters while developing and maintaining effective communication with GFD leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement project work safely with quality, speed, and value.
- Compliance: Lead with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.
- Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification.

**Minimum Requirements:**

- Bachelor of Science in Engineering or a technical related field (i.e. project management, construction management).
- Minimum of 10+ years previous experience in capital project delivery in industrial or manufacturing facilities (preferably leading projects/multiple projects \>$100MM in size).
- Previous experience managing greenfield projects.

**Additional Preferences:**

- Pharmaceutical manufacturing experience
- Capital Project Management Experience in pharmaceutical manufacturing facilities such as: Bulk API, sterile products, secondary packaging, devices, and to a lesser extent, lab projects
- Experience in the following areas: GMP manufacturing, LEAN, automation, construction, construction quality, CQV (commissioning, qualification, and validation), project controls, the engineering disciplines, safety, and scheduling
- The capacity to achieve results and influence through people
- Demonstrated ability to manage interface risk and scope boundaries across multiple design/construction contractors on a single program
- Demonstrated ability to work from long distances with little supervision (ability to make decisions without managerial approval while keeping management informed/engaged on critical issues)
- Effective communication skills, both written and verbal
- Ability to influence personnel and organizations without having direct administrative responsibility for them
- Competency in a foreign language(s)
- Professional Engineer (PE) or equivalent technical certification
- Project Management Professional (PMP) certification
- Experience in working and/or living outside the U.S.
- Willingness to relocate and/or travel to locations outside of home state/country.
- Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change

**Additional Information:**

- International travel is likely required in this role and may include weekends and multi-week stays (15% to 30% travel, domestic and international).
- The position will require full relocation to the project location in Houston, TX for the duration of the project. Onsite presence required (this is NOT a remote role).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$129,000 - $209,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Agentic AI Solutions, Associate Director

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Overview**

At Lilly, we serve an extraordinary purpose. For nearly 150 years we have worked tirelessly to discover medicines that make life better. In Product Research and Development (PRD), we transform molecules into medicines, working through an increasingly external partner network across drug substance, drug product, and analytical services.

PRD's External Supply Chain & Operations (ESCO) team stewards this external partner network — delivering supplier excellence, systematic and scalable sourcing workflows, supply chain design, technical-transfer processes, and end-to-end network performance across drug substance, drug product, and analytical services.

As ESCO scales a harmonized supplier governance model and moves toward AI-enabled, agentic sourcing operations, it requires a net-new capability: hands-on agentic AI and applied ML expertise dedicated to building practical tools and autonomous agents for PRD's sourcing systems and business processes. This is a new position for the team, modeled on the agentic AI engineering capability DDCS has built within its Digital Transformation and Data Science team, adapted for ESCO's external-sourcing context.

**The Opportunity**

Today, ESCO sourcing leads spend significant time manually working through CDMO/CMO proposals, capacity data, technical-transfer records, audit and quality documentation, contracts, and supplier scorecards scattered across email, SharePoint, and Teams — to answer questions such as which partners have capacity for a given modality next quarter, how a partner performs across modalities, or where a program's technical transfer stands and what is blocking it. This role builds the agentic AI tools and systems that turn that manual, document-heavy work into fast, reliable, AI-assisted decisions.

The Agentic AI Solutions Lead is a hands-on, full-stack build role responsible for designing, building, and deploying AI-enabled workflows, agentic sourcing systems, and document-intelligence tools that help ESCO colleagues turn complex CDMO/CMO information into actionable sourcing decisions. This is a builder role, not an architecture-and-handoff role: the individual personally develops and ships working agents and applications, in partnership with Tech@Lilly and PRD Strategy where enterprise platforms and standards intersect.

The role bridges ESCO, PRD Strategy's End-to-End Supply Chain Design Process, Procurement, and Tech@Lilly — fluent in both the business realities of external sourcing (RFx, technical transfer, supplier governance, capacity planning) and the applied AI/ML engineering needed to automate them responsibly and at scale.

**Key Responsibilities**

**AI Solutions Engineering & Practical Tool Delivery**

- Partner with ESCO sourcing operations leads and category managers to identify, prioritize, and scope high-value opportunities where agentic AI, machine learning, and automation can improve speed, productivity, insight generation, and decision quality across the CDMO/CMO network.
- Translate stakeholder needs into practical AI tools, technical designs, acceptance criteria, and delivery plans that fit real sourcing, supplier-management, and technical-transfer workflows.
- Build and deploy AI-enabled applications, services, and workflows that integrate models, sourcing data sources, document collections, and user-facing interfaces for decision support and workflow automation.

**Agentic Sourcing AI Systems & Knowledge Extraction**

- Create reusable agent skills, task harnesses, validators, run ledgers, and reproducibility controls that allow AI agents to execute diverse, long-running sourcing tasks reliably (e.g., capacity assessment, RFx analysis, technical-transfer status tracking).
- Build agentic knowledge extraction and question-answering systems for structured and unstructured sourcing content, including CDMO proposals, quality/audit reports, contracts, capacity data, technical-transfer records, and supplier scorecards.
- Design evaluation, monitoring, guardrails, and human-in-the-loop escalation patterns so agentic outputs are auditable, traceable, and appropriate for high-consequence sourcing and supply-continuity decisions.
- Apply knowledge graphs, data ontologies, and structured knowledge representation where they improve retrieval, traceability, and reuse across the supplier and CDMO network.

**Decision Support & Workflow Transformation**

- Build the PRD Supply Chain Intelligence (AI) agent end to end — from feasibility through pilot to production — as a core deliverable of this role, in coordination with Tech@Lilly and PRD Strategy's End-to-End Supply Chain Design Process.
- Turn information from CDMO/CMO documents, sourcing systems, and business processes into faster insights, stronger judgment, and improved ways of working across ESCO.
- Communicate model outputs, evidence, assumptions, limitations, uncertainty, and recommended actions through clear visualizations and decision-support outputs that influence solution adoption and sourcing decisions.

**Reliability, Validation, MLOps & Responsible AI**

- Champion software engineering best practices including version control, automated testing, CI/CD, containers, documentation, reproducibility, observability, and fit-for-purpose MLOps/agent-ops practices.
- Develop validation, monitoring, documentation, and model-risk approaches aligned with intended use, responsible AI principles, GxP awareness, and regulatory expectations where applicable to sourcing and supply-chain decisions.
- Leverage cloud infrastructure to develop, test, deploy, and scale agentic workflows, document-intelligence systems, and analytics applications supporting ESCO.

**Cross-Functional Collaboration & Scientific/Business Translation**

- Partner across ESCO, PRD Strategy, Procurement, PRD functional leaders (Drug Substance, Drug Product, Analytical, Packaging), and Tech@Lilly to align agentic tools with enterprise data and platform standards, including the Portfolio Intelligence Hub and the CS&D Supply Chain Control Tower.
- Coordinate with Tech@Lilly's formal CRO data exchange and digital workflow for CMC lab experiments so ESCO's agentic tools adopt existing digital exchange pathways rather than creating parallel ones.
- Translate complex AI findings into clear narratives and business cases that influence solution adoption, workflow redesign, and sourcing-team priorities.

**Capability Building, External Leadership & Mentorship**

- Advance ESCO's technology roadmap for practical agentic AI tools, document intelligence, and reusable knowledge systems, drawing on DDCS's Digital Transformation and Data Science team as a cross-org reference and collaboration partner.
- Share methods, reference patterns, and lessons learned that help ESCO embed agentic AI into everyday sourcing work.
- Mentor team members and partners on reliable agentic systems, responsible AI, and rigorous communication of model assumptions, uncertainty, and decision impact.
- Stay current with the fast-moving agentic AI and LLM landscape and bring new tools, frameworks, and techniques into ESCO's practice where they add real value.

**First-Year Outcomes**

**Success in this role is defined by what exists after hire:**

- **By month 6:**  First agentic AI pilot (e.g., CDMO capacity or technical-transfer status assistant) live with named users; document-intelligence extraction pipeline operating over a defined CDMO/CMO document set; PRD Supply Chain Intelligence agent feasibility assessment complete with a go/no-go recommendation.
- **By month 12:**  PRD Supply Chain Intelligence agent in production pilot with defined evaluation criteria and monitoring in place; at least one additional agentic workflow adopted into standard ESCO sourcing operations; reusable agent skills and evaluation framework established for future ESCO AI use cases.

**Basic Qualifications**

- Earned Master's degree and a minimum of 5 years of post-degree experience in Computational/Computer Science, Machine Learning, Artificial Intelligence, Engineering, or closely related STEM quantitative field.
- 2+ years of applied technical work building AI or machine learning solutions in a programming language such as Python/R, with working knowledge of the ecosystem (NumPy, pandas, PyTorch, scikit-learn, or related).
- 3+ years of expertise in strategic thinking, problem framing, and translating ambiguous business needs into tractable AI, modeling, or automation workflows.
- Demonstrated ability to frame ambiguous sourcing or supply-chain business needs as tractable AI, modeling, or computational workflows.
- Skill in communicating technical recommendations with clearly stated assumptions, uncertainty, and limitations, to sourcing, procurement, and business audiences.

**Additional Preferences**

- Earned PhD in a relevant field and 2+ years of post-degree experience in Computational/Computer Science, Machine Learning, Artificial Intelligence, Engineering, or quantitative field.
- Experience applying AI/ML to pharmaceutical, life-sciences, or supply-chain/sourcing problems (prior biology or life-sciences background not required).
- Familiarity with pharmaceutical or regulated-industry supply chains preferred; partners closely with sourcing subject-matter experts across ESCO to build necessary modality- and process-specific context.
- Strong SQL and relational data modeling, with comfort turning large, messy, unstructured, or incomplete sourcing data into reliable, decision-ready output.
- Hands-on experience with cloud platforms and solid engineering practice: Git, containers, CI/CD, and experiment or run tracking.
- Experience with knowledge graphs, ontologies, or structured knowledge representation for supplier, contract, or technical content.
- Fluency with agent frameworks and orchestration (LangGraph, AutoGen, CrewAI, or equivalent) and the primitives underneath them: planner/executor splits, hand-offs, escalation logic, and state management across multi-step or multi-session workflows. Knowing why they fail, not just how to call them.
- End-to-end RAG design over messy commercial and technical documents: parsing and layout extraction from PDFs, scans, and tables; chunking strategy; hybrid search; reranking; embedding models; and vector stores (pgvector, Pinecone, Weaviate, or similar).
- LLM engineering judgment: context design, tool/function calling (MCP or comparable standards), structured output design at scale, and knowing when to fine-tune versus retrieve versus prompt.
- Evals engineering: golden datasets and benchmarks, automated regression suites, and failure-mode tracking. Evidence of a trustworthy agent shipped to production.
- LLMOps in production, treating cost, latency, and reliability as engineering constraints with the monitoring to match.
- Guardrail and safety design for autonomous systems: approval gates, rollback logic, hallucination and drift detection, and model-risk thinking for high-consequence sourcing decisions.
- Evidence of contribution to significant work, ideally through publications at relevant ML/AI/NLP venues (NeurIPS, ICML, ICLR, ACL, EMNLP) or comparable open-source or applied contributions.
- Self-directed and comfortable operating in a net-new, still-evolving capability area with limited existing precedent.
- Strong business acumen and ability to operate effectively in ambiguity.

**Additional Information**

- Travel: 0 to 10%.
- Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N). This is an on-site 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](<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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$118,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Director/Sr Director, Injection Physiology & Parenteral Delivery Science

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Overview**

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Drug Delivery group at Lilly studies physiological barriers across routes of administration to create novel, patient-centric delivery solutions, serving as a center of excellence in injection physiology, device ideation, novel drug delivery technologies across modalities and routes of administration, nanomedicine and targeted delivery, and connected devices/digital biomarkers.

**Position Overview:**

Teh Director/Sr Director, Injection Physiology & Parenteral Delivery Science leads and directs the group's injection physiology and parenteral delivery science team — the scientists and engineers who quantify how injection parameters (flow rate, volume, viscosity, needle geometry, and injection depth) govern local tissue response, injection-site reactions, drug distribution, and systemic exposure across subcutaneous, intradermal, and intramuscular routes, and who build the ex-vivo tissue models, imaging, rheology, and biofluid-dynamics/CFD workflows that enable higher-concentration and higher-volume delivery.

We are seeking a hands-on, senior technical leader to set scientific direction for this portfolio while leading, coaching, and developing a team of junior scientists — providing day-to-day technical guidance, prioritization, and mentorship — and operating at the enterprise level: representing Lilly externally with academic, clinical, and regulatory stakeholders and translating injection-physiology understanding into device-design, formulation, and dose-selection decisions across the pipeline. The role carries accountability for growing the team's talent and for translating injection-physiology science from mechanistic understanding into design-control- and clinic-ready delivery solutions.

**Key Responsibilities:**

- Lead and direct the injection physiology and parenteral delivery science team: set the scientific vision and multi-year technical strategy, prioritize the portfolio across programs, and provide day-to-day scientific direction to junior scientists and engineers, aligned with the group's portfolio bets and enterprise R&D priorities.
- Serve as Lilly's internal and external technical authority on injection physiology — including injection biomechanics, tissue deformation and injection-site response, and the flow-rate, volume, and viscosity drivers of injectability and systemic exposure; lead cross-functional teams to translate mechanistic findings into device and formulation decisions, leveraging AI/ML-enabled modeling and data-analysis tools to accelerate technical decision-making.
- Build and leverage an external network of academic collaborators (e.g., university injection-physiology and computational-modeling programs), CROs, and regulatory bodies (e.g., FDA); represent Lilly's injection physiology work in publications, conferences, and regulatory discussions.
- Design and oversee preclinical and clinical injection-physiology study strategy — ex-vivo tissue models, imaging, rheology, and biofluid-dynamics/CFD workflows — with internal teams and CRO/academic partners to de-risk device-design and dose-selection decisions; champion breakthrough approaches and make data-driven, sometimes bold, decisions under scientific and technical ambiguity where no precedent exists.
- Coach, mentor, and develop the injection physiology team — setting individual development goals, reviewing scientific work, and growing the capabilities of junior scientists — and identify and lead scientific or process improvements that draw on diverse thinking across DDCS's broader technical portfolio.

**Basic Qualifications:**

- Earned PhD in biomedical/mechanical engineering, pharmaceutical sciences, biophysics, or a related field.
- 8+ years of relevant industry/translational experience in injection physiology, subcutaneous/parenteral delivery, or injection biomechanics, including: demonstrated depth in the tissue-mechanics and fluid-dynamics drivers of injectability, injection-site response, and systemic exposure.
- Demonstrated ability to bridge preclinical injection-physiology understanding — or a directly comparable delivery-science discipline — into device-design, formulation, or dose-selection decisions
- Working knowledge of design controls and quality systems in a regulated industry.
- Effective, hands-on use of AI/ML-enabled tools (e.g., large language models, computational modeling copilots, literature-synthesis or data-analysis assistants) to accelerate scientific research, technical writing, and translational planning
- Demonstrated ability to lead, direct, and develop scientists — including setting technical direction and priorities for, and growing the capabilities of, junior team members, including staff outside a direct reporting line.
- A publication and/or patent record demonstrating recognized technical contribution in injection physiology or parenteral delivery
- Excellent scientific communication skills across technical/non-technical and internal/external audiences.

**Additional Preferences:**

- Experience building and sustaining external scientific relationships (academic labs, consortia, key opinion leaders); comfort representing an organization's technical position externally.
- Experience with ex-vivo tissue models, injection-force/rheology characterization, medical imaging or biofluid-dynamics/CFD modeling (e.g., COMSOL or equivalent), or human-factors/injection-experience research is a plus but not required if compensated by deep injection-physiology leadership and expertise.

**Other Information:**

- Hands-on in-Lab Requirement: 25-50%
- Travel Percentage (%): 10-15

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](<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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$153,000 - $264,000

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

Sr. Principal Associate - HSE - Waste Programs

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Facilities Management and Engineering Services (GFMES) Health, Safety and Environmental (HSE) department provides technical expertise and solutions to a broad and diverse customer base to identify and mitigate workplace HSE risk. We collaborate with business areas to understand their challenges and partner with them to implement right sized operational compliance strategies, management systems and best practices in an effective and efficient manner. We combine high-quality counsel with decades of practical experience across a wide variety of industries. Our mission is to engage both Lilly employees and our contract partners in the company’s goal of achieving an injury-free workplace and ensuring that our business operations contribute to a cleaner, safer environment.

Within GFMES HSE, the Indianapolis Environmental Services (IES) team owns environmental compliance and program execution across the Lilly Indianapolis campuses and supports environmental compliance for designated multi-site and national operations. IES delivers air, water, and waste compliance programs, regulatory agency interface, permitting support, and environmental risk reduction for a large, complex, and rapidly growing manufacturing and research footprint.

**Responsibilities:**

The GFMES Sr. Principal Associate – Environmental position serves as the senior technical authority and program owner for waste management within the Indianapolis Environmental Services (IES) team. This role sets program direction, establishes standards and governance, and applies senior-level judgment to complex, high-risk, and novel waste issues across hazardous, non-hazardous, universal, and other regulated waste streams generated at the Lilly Indianapolis campuses and designated supported operations. The position is accountable for the effectiveness of the waste management program, not solely its execution, including compliance assurance, third-party service provider strategy and performance, long-term liability reduction, and the capability of the broader organization to meet waste requirements. The role influences engineering, manufacturing, procurement, sustainability, and site leadership to integrate waste considerations into business and capital decisions and represents IES on waste matters with regulatory agencies and across the GFMES HSE network.

Specific responsibilities include but are not limited to:

- Serve as Program Owner and recognized Subject Matter Expert for hazardous and non-hazardous waste management across supported Indianapolis campuses and designated multi-site operations.
- Define and advance a multi-year waste management strategy for the Indianapolis site network covering compliance, waste minimization, circularity, vendor strategy, and long-term liability reduction, aligned to Lilly HSE priorities and sustainability commitments.
- Establish, maintain, and continuously improve waste management standards, procedures, and governance frameworks, including accountability models for activities executed by third parties.
- Apply senior-level technical judgment to complex, ambiguous, and first-of-a-kind waste issues where clear regulatory precedent does not exist and make defensible recommendations under uncertainty.
- Ensure compliance with RCRA (40 CFR 260–273), Indiana hazardous waste rules (329 IAC), DOT hazardous materials requirements (49 CFR / HMR), land disposal restrictions, and applicable internal Lilly HSE standards.
- Own waste determinations, profiles, manifests, land disposal restriction notifications, biennial reports, and generator status documentation, including review and approval of complex or contested determinations.
- Own strategic and technical relationship with third-party waste service providers, including scope definition, performance standards, cost and invoice governance, non-conformance escalation, and corrective action closure.
- Lead treatment, storage, and disposal facility (TSDF) qualification, approval, and periodic reassessment, including on-site audits of vendor facilities and transporters, and recommend disposal pathways based on technical suitability and long-term liability exposure.
- Lead regional waste vendor sourcing strategy, RFP development, technical bid evaluation, negotiation support, and transition execution in partnership with Procurement.
- Lead waste minimization, recycling, reuse, and resource recovery initiatives to reduce generation at the source and improve diversion performance, including business case development for proposed changes.
- Set direction for digital waste tracking, electronic manifesting, and environmental data and reporting platform capability, including requirements definition, platform evaluation input, and implementation oversight.
- Provide waste management leadership for capital projects, facility start-ups, equipment decommissioning, demolition, and construction activities, including waste characterization, disposal pathway selection, and design-stage influence.
- Lead self-assessments, compliance audits, and inspections for assigned programs; identify systemic root causes and drive corrective and preventive actions to closure.
- Serve as a primary technical point of contact for regulatory agency interactions and inspections (IDEM, U.S. EPA, local authorities) on waste matters, including information requests and response strategy.
- Serve as root cause analysis (RCA) investigator for waste-related incidents and deviations and document in the applicable quality/HSE system. RCA training will be provided as needed.
- Own tracking and interpretation of external waste regulatory developments, assess business impact, and translate changes into actionable internal requirements for the GFMES business area.
- Influence Engineering, Manufacturing, Procurement, Sustainability, Quality, and Legal to integrate waste management considerations into design decisions, capital projects, and operational changes.
- Build organizational capability through training, technical guidance, and communications, and by mentoring and providing technical coaching to less experienced environmental professionals and generator-area personnel.
- Provide input to IES business planning, capital and expense budget development, and resource prioritization for waste program areas.
- Represent Lilly and IES, as appropriate, in industry groups, benchmarking forums, and trade associations on waste management practice and emerging regulatory developments.
- Provide waste management technical leadership to designated multi-site and national operations as assigned.

**Basic Requirements:**

- Bachelor’s degree in environmental science, Environmental Engineering, Chemical Engineering, or a related technical discipline.
- Minimum 10 years of professional experience in hazardous and non-hazardous waste management.
- Deep working knowledge of RCRA, DOT/HMR hazardous materials transportation requirements, and state hazardous waste regulations.
- Hands-on experience with waste characterization, profiling, manifesting, and disposal pathway selection.
- Extensive experience in the waste management services industry, gained with a national or regional hazardous waste transportation, treatment, and disposal service provider, in a field service, technical service, compliance, or account management capacity.
- Demonstrated experience owning an environmental program end to end, including standards, governance, performance metrics, and continuous improvement.
- Demonstrated ability to influence and align cross-functional stakeholders and site leadership without direct authority.
- Demonstrated judgment evaluating complex or ambiguous environmental risk and producing practical, business-aligned recommendations.
- 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.

**Additional Skills/Preferences:**

- Working knowledge of hazardous waste treatment and disposal technologies, including incineration, fuels blending, stabilization, wastewater treatment, and landfill, and the ability to evaluate disposal pathway suitability and long-term liability.
- Direct experience conducting or hosting TSDF and transporter audits.
- Experience in pharmaceutical, chemical, or another highly regulated manufacturing environment.
- Experience establishing waste standards, governance models, or program frameworks across a multi-site organization.
- Experience overseeing environmental compliance activities executed by third parties, including accountability and oversight models.
- Experience with commercial waste contracting, pricing structures, and vendor performance management.
- Familiarity with electronic manifesting (e-Manifest) and waste data management or environmental compliance software platforms.
- Experience supporting decommissioning, demolition, or remediation waste streams.
- Experience mentoring or providing technical direction to other environmental professionals.
- Familiarity with Lilly Indianapolis sites; Lilly Corporate Center, Lilly Technology Center, and business areas at each site.
- Advanced interpersonal, relationship management, and influencing skills across contract partners, site operations, and leadership.
- Advanced ability to translate technical and regulatory complexity into clear recommendations for site and senior leadership.
- Effective project, organization, and time management skills.
- Computer skills proficiency (e.g., Outlook, Teams, SharePoint, PowerPoint, Word, Excel).
- Professional certification/license (e.g., CHMM, PE, CSP, or equivalent).

**Additional Information:**

- Position based at Lilly Technology Center Campus – South (LTC-S), Indianapolis, IN.
- Position will require work at other Lilly Indianapolis area locations and possible US regional sites.
- Normal work week M-F. Onsite presence is required the majority of the time. This is not a remote role.
- Work involves regular presence in manufacturing, laboratory, warehouse, and outdoor waste accumulation areas; use of required personal protective equipment is expected.
- Travel is possible, infrequent, estimate less than 15% of the time, including travel for vendor facility and TSDF audits and support to designated multi-site operations.

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](<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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$101,250 - $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

Sr. Project Manager

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

Syner-G is seeking a Senior Project Manager to lead strategic client initiatives and complex capital projects while establishing and advancing project governance, operating models, organizational effectiveness, and portfolio management practices. This role is responsible for driving project execution, stakeholder alignment, executive decision-making, and performance management across multiple workstreams and project teams.

The Senior Project Manager will serve as a trusted advisor to client leadership, developing governance frameworks, stakeholder engagement strategies, executive communications, and project delivery methodologies that support successful outcomes. This role requires a unique blend of project management expertise, strategic thinking, executive presence, and organizational change leadership to ensure initiatives are delivered on schedule, within budget, and aligned with business objectives.

**WORK LOCATION:**

Travel to client sites may be required up to 100%, based on project demands and client expectations.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented or adjusted as necessary.)

- Develop and implement project governance frameworks, operating models, decision-making structures, and management routines that support effective execution and accountability.
- Establish portfolio management processes, reporting frameworks, and performance measurement systems across multiple projects and initiatives.
- Lead governance meetings, steering committees, and executive reviews, ensuring timely escalation and resolution of risks, issues, and decisions.
- Partner with client leadership to align project delivery strategies with organizational objectives and business priorities.
- Drive organizational effectiveness initiatives that improve project delivery, team collaboration, operational efficiency, and decision-making.
- Develop stakeholder engagement, communication, and executive engagement strategies across leadership teams, project teams, and external partners.
- Create executive presentations, strategic communications, dashboards, and leadership reports that translate complex information into clear, actionable insights.
- Prepare compelling narratives and recommendations to support executive decision-making and organizational alignment.
- Facilitate communication between senior leadership, project stakeholders, contractors, and technical teams.
- Manage stakeholder expectations, resolve conflicts, and ensure alignment across project and business objectives.
- Establish and maintain portfolio reporting, KPIs, performance metrics, scorecards, and executive dashboards.
- Monitor project performance and provide data-driven recommendations to improve delivery outcomes.
- Identify, assess, and manage project, program, and organizational risks while developing mitigation and contingency plans.
- Keep the Project Director and executive stakeholders informed of project risks, issues, progress, and recommended solutions.
- Lead lessons learned reviews and continuous improvement initiatives to strengthen project delivery capabilities.
- Act as the owner's representative on capital projects, ensuring alignment with client expectations and project goals.
- Review technical submissions from Architectural and Engineering (A&E) firms, including MEP drawings, structural drawings, and construction specifications.
- Respond to and manage construction communications such as RFIs, submittals, and technical clarifications.
- Assist with and oversee preparation of project startup and closeout documentation.
- Read, interpret, and manage project plans, specifications, contracts, subcontracts, purchase orders, correspondence, shop drawings, and other project-related documentation.
- Maintain complete and accurate as-built documentation throughout the project lifecycle.
- Manage Transfer of Care and Custody (TOCC) activities and ensure successful transition to facility operations.
- Utilize Microsoft Project and project management platforms such as ProCore, E-Builder, or Prolog to develop, maintain, and monitor project schedules and execution plans.
- Lead project meetings, track action items, and drive accountability across project teams.
- Conduct regular site visits to verify project progress, identify field issues, and implement solutions.
- Prepare project status reports, progress measurements, and executive updates.
- Coordinate contractors, construction managers, engineering teams, and specialty trades to ensure successful project execution.
- Support startup, commissioning, and turnover activities for facility and building systems.

**QUALIFICATIONS AND REQUIREMENTS:**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

*Education:*

- Bachelor's degree in Engineering, Construction Management, Information Management, Business, or related field; equivalent experience may be considered.

*Technical Experience:*

- 8–14 years of experience as a project engineer or project manager, preferably in the petrochemical, chemical, refining, or related industrial sectors.
- Experience managing major capital projects from design through construction, commissioning, and handover.
- Experience supervising and coordinating contractors across multiple disciplines (GC, CM, mechanical, electrical, etc.).
- Experience executing projects within active operating facilities.
- Experience with commissioning and turnover of building systems such as HVAC, emergency power, UPS, lab gases, RODI water, boilers, and steam systems.
- Experience conducting site walks, identifying field issues, and developing solutions.
- Experience leading daily planning meetings and documenting project activities.
- Experience preparing daily reports, photo documentation, and progress tracking.
- Experience reviewing safety documentation and collaborating with EHS teams.

*Knowledge, Skills, and Abilities:*

- Strong communication skills with the ability to interface effectively with client stakeholders, managers, contractors, and subcontractors.
- Proficiency with Microsoft Project and familiarity with construction management software.
- Detail-oriented with strong analytical, organizational, and problem-solving skills.
  Ability to manage multiple priorities in a fast-paced environment.

*Preferred Qualifications:*

- Experience within pharmaceutical, biotechnology, life sciences, or GMP-regulated environments.
- Experience supporting large-scale facility construction, expansion, retrofit, or manufacturing site programs.
- Experience with Autodesk Construction Cloud, BIM/CDE environments, or other Autodesk information-management platforms.
- Experience integrating documentation processes with Primavera P6, MS Project, or other project scheduling tools.
- Familiarity with project controls processes including schedule, cost, change control, risk, and reporting.
- Experience supporting project turnover, commissioning, qualification, or operational readiness documentation.
- Experience developing document-management procedures, SOPs, workflows, and governance standards.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

**COMPENSATION:**

The expected salary range for this position is $150,000 to $170,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Senior Validaiton Engineer

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

We are seeking a CQV Engineer with 7–11 years of experience supporting commissioning, qualification, and validation activities for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes. This role is responsible for the execution of commissioning and qualification activities, including system walkdowns, protocol execution, documentation review, discrepancy management, and system turnover support. The CQV Engineer will work cross-functionally with Engineering, Construction, Automation, Operations, Quality, and project teams to ensure systems are installed, tested, documented, and released in accordance with approved requirements, project timelines, and regulatory expectations.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented or adjusted as needed.)

- Review approved design, vendor, turnover, and qualification documentation in preparation for commissioning and qualification execution activities.
- Support system walkdowns, field verification activities, construction completion reviews, and readiness assessments.
- Execute commissioning and qualification protocols, including IQ, OQ, PQ, functional testing, and other approved test documentation as applicable.
- Verify installation of equipment, utilities, instrumentation, controls, and automation systems against approved drawings, specifications, vendor documentation, and design requirements.
- Verify system functionality, alarms, interlocks, controls, instrumentation, and operational requirements during execution activities.
- Coordinate testing activities with Engineering, Construction, Automation, Operations, Quality Assurance, and equipment vendors to support execution schedules.
- Perform and document field testing activities and collect objective evidence required to support protocol execution and qualification deliverables.
- Identify, document, and track discrepancies, punch-list items, protocol exceptions, and deviations encountered during execution activities.
- Support investigations, issue resolution, corrective actions, retesting, and closure of execution-related deviations and discrepancies.
- Perform protocol data review and ensure documentation is complete, accurate, attributable, and compliant with GMP documentation requirements.
- Review turnover packages and verify supporting documentation required for system acceptance and qualification.
- Develop and complete qualification summary reports, turnover documentation, and system closeout packages.
- Support system release and handover activities to Operations and Quality upon successful completion of required CQV deliverables.
- Maintain execution status and communicate progress, constraints, project risks, and dependencies to CQV and project leadership teams.
- Participate in project meetings and collaborate with cross-functional stakeholders to ensure alignment with project schedules and milestones.
- Support regulatory inspections, audits, and quality initiatives as they relate to commissioning, qualification, and validation activities.

**QUALIFICATIONS AND REQUIREMENTS**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

*Education*

- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.

*Technical Experience*

- 7–11 years of commissioning, qualification, validation, engineering, or related experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industries.
- Strong understanding of FDA cGMP requirements, GDP documentation practices, and risk-based commissioning and qualification methodologies.
- Experience supporting commissioning and qualification activities for process equipment, clean utilities, facilities, automation systems, and manufacturing systems.
- Demonstrated experience executing and/or supporting IQ, OQ, PQ, commissioning, startup, and functional testing protocols.
- Experience reviewing engineering documentation, including P&IDs, specifications, equipment drawings, turnover packages, and vendor documentation.
- Familiarity with deviation management, discrepancy resolution, change control processes, and quality systems.
- Experience supporting startup, construction completion, system turnover, and operational readiness activities is preferred.
- Experience working in large capital project environments and collaborating with multidisciplinary project teams is preferred.

*Knowledge, Skills, and Abilities*

- Strong knowledge of commissioning, qualification, and validation principles within GMP-regulated environments.
- Ability to execute protocols in the field and effectively document testing results and objective evidence.
- Strong organizational skills with attention to detail and documentation accuracy.
- Excellent verbal and written communication skills with the ability to interact with stakeholders across multiple functional groups.
- Ability to manage multiple priorities and work effectively in a fast-paced project environment.
- Strong problem-solving skills and ability to support investigations, issue resolution, and risk mitigation activities.
- Ability to work independently while contributing effectively as part of a cross-functional project team.
- Proficient with Microsoft Office applications and electronic quality/documentation systems.

**ESSENTIAL FUNCTIONS:**

*Physical Demands:*

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as navigate production, utility, construction, and manufacturing areas. The employee may occasionally be required to stand for extended periods, climb stairs, stoop, kneel, or lift and carry objects weighing up to 25 pounds. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment:*

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Duties will be performed in a combination of office, laboratory, manufacturing, utility, and construction environments. The employee may be exposed to varying noise levels and active project areas while supporting field execution, system walkdowns, and qualification activities. Appropriate personal protective equipment (PPE) may be required when working in designated operational or construction environments.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston, San Diego, CA, Boulder, CO, and India.

**COMPENSATION:**

The expected salary range for this position is $120,000 to $140,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Sr. Automation Engineer

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

We are seeking a Sr. Automation Engineer with 5-15 years of experience to serve as a subject matter expert for automation MES, providing QA/Validation oversight for Manufacturing Execution System (MES) and Electronic Batch Record (eBR) implementations, qualification activities, and system lifecycle management. This individual will partner closely with Manufacturing, Quality, Validation, Automation, and IT/OT teams to ensure successful system deployment, qualification, and ongoing compliance.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented or adjusted as needed.)

- Own and develop Functional Requirements Specifications (FRS), translating manufacturing processes and business needs into clear MES functional requirements.
- Work closely with Manufacturing SMEs and MES technical/configuration teams to ensure the solution accurately reflects intended manufacturing processes and operator workflows.
- Plan, coordinate and execute User Acceptance Testing (UAT), including development of test scenarios and coordination with Operations SMEs.
- Review and challenge electronic batch records, recipes, workflows, calculations, prompts, exception handling and user interactions from an operational perspective.
- Support operational readiness, including dry runs, mock batch execution and go-live preparation.
- Develop and deliver MES/eBR user training and support operator readiness.
- Provide hands-on floor support during go-live, hypercare and stabilization.
- Troubleshoot MES/eBR workflow and usability issues across Manufacturing, Quality, Automation, IT/OT and MES teams.
- Support validation and qualification activities as required, ensuring alignment with GMP and site procedures.

**QUALIFICATIONS AND REQUIREMENTS:**

*Education*

- Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.

*Technical Skills:*

- Strong pharmaceutical manufacturing/Operations background combined with hands-on MES experience.
- Demonstrated ability to translate shop-floor manufacturing processes into functional MES requirements and workflows.
- Experience developing FRS/user requirements and supporting MES solution design.
- Hands-on experience with UAT, eBR testing, operational readiness and go-live support.

*Knowledge, Skills and Abilities:*

- Previous experience as a manufacturing operator, technician, manufacturing associate or Operations SME is highly desirable.
- Experience with PAS-X, PharmaSuite, Syncade, Opcenter or similar MES/eBR platforms preferred.
- Working knowledge of GMP, 21 CFR Part 11, data integrity and validation requirements.
- Strong communication skills with the ability to work effectively between Operations and technical MES teams.
- Ability to mentor junior engineers and contribute to team development and knowledge sharing.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

North Carolina

Senior Validation Engineer (QAV)

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

We are seeking a Senior Validation Engineer (QAV) with 4-15 years of experience to support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures.

The Senior Validation Engineer (QAV) will support MES and eBR implementation and qualification activities, working closely with cross-functional teams including Manufacturing, Validation, Automation, IT/OT, and Quality. The successful candidate will contribute to validation strategy, execution, documentation review, and system release activities while ensuring alignment with GMP and computerized systems validation requirements.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented or adjusted as needed.)

- Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and validation reports for equipment, utilities, facilities, computerized systems, and other GMP-regulated assets.
- Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management activities.
- Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports to ensure compliance with approved validation methodologies.
- Review eBR workflows to verify alignment with approved manufacturing processes, master batch records, and regulatory requirements.
- Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements.
- Assist with deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities.
- Author, execute, review, and maintain validation documentation including validation plans, protocols, reports, SOPs, URS, FRS, and design specifications.
- Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements.
- Prepare validation summary reports and support qualification and requalification activities.
- Participate in commissioning and qualification activities, including system walkdowns and verification exercises.
- Support thermal mapping and validation activities for temperature-controlled environments and systems, as applicable.
- Assist in the resolution of audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems.
- Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to support successful project execution and operational readiness.
- Maintain validation documentation in accordance with quality system requirements and document control procedures.

**QUALIFICATIONS AND REQUIREMENTS:**

*Education*

- Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.

*Technical Experience*

- Provide QA/validation oversight for MES and eBR implementation and qualification.
- Review and approve requirements, risk assessments, test protocols, deviations, traceability, and validation reports.
- Review eBR workflows for alignment with approved manufacturing processes and batch records.
- Ensure compliance with 21 CFR Part 11, GMP, data integrity, and CSV requirements.
- Support deviation investigations, change controls, system release, and go-live activities.
- Work closely with Manufacturing, Validation, Automation, IT/OT, and Quality teams.

*Knowledge, Skills, and Abilities*

- Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and computerized systems validation requirements.
- Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment.
- Strong technical writing and documentation skills with attention to detail.
- Ability to review and interpret validation documentation, process flows, requirements specifications, and test scripts.
- Strong organizational, analytical, and problem-solving abilities.
- Effective verbal and written communication skills with the ability to collaborate across multiple functional areas.
- Ability to manage multiple assignments and priorities in a fast-paced project environment.
- Working knowledge of validation lifecycle deliverables and quality system processes.
- Ability to work independently while contributing effectively within cross-functional teams.
- Demonstrated MES/eBR validation experience.
- Experience with PAS-X, PharmaSuite, Syncade, Opcenter, or similar MES platforms preferred.
- Strong understanding of GMP manufacturing, 21 CFR Part 11, data integrity, and validation lifecycle documentation.
- Strong technical writing, documentation review, and cross-functional communication skills.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.