Senior Engineer - HSE Advanced Therapies Manufacturing at Eli Lilly and Company

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.

Senior Engineer - HSE Advanced Therapies Manufacturing

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

Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Advanced Therapies in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply. 

Main Purpose and Objectives of Position: 

The Senior Engineer is part of the Lilly Lebanon Advanced Therapies Health, Safety, and Environmental (HSE) team and provides technical leadership and expertise in the development, implementation, and maintenance of HSE programs. This role focuses primarily on Health and Safety programs but may include Environmental programs, as needed.

In the project delivery and startup phases, the HSE roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows through startup to full scale GMP manufacturing.

Post start-up, this role will continue to be the be the subject matter expert for assigned HSE programs and serve as an HSE regulatory advisor for manufacturing and support units.

Key Responsibilities for this role include:

Pre-Startup and Startup Phase:

• Provide collaborative, inclusive, and energetic leadership while supporting the broader HSE team and other functions as needed across all aspects of operational readiness and startup, including definition and development of tools and coaching needed to achieve HSE compliance and a positive site culture.
• Collaborate with the Associate Director HSE to identify and define the necessary capabilities, capacity, and priorities needed to build an HSE organization and culture that will operate and support the site to the highest standards of HSE and operational excellence by leveraging existing Lilly guidelines and incorporating external experiences and knowledge.
• Support the project team to deliver the facility as a key stakeholder providing feedback and support on HSE related design decisions and startup plan while ensuring decisions meet project deliverables and compliance requirements.
• Build technical relationships with the relevant corporate/global and as needed and support strategic corporate initiatives at the site level.
• Assist with the development of the HSE programs for the Lilly Lebanon Advanced Therapies facility as a collaborative, inclusive, and energetic member of the HSE team.
• Lead implementation of assigned HSE programs, such as lockout tagout, PPE, hazard communication, ergonomic hazards, confined space entry, machine guarding, working at heights, powered industrial vehicles, health and safety risk assessments, etc.
• Support the project team to deliver the facility as a key stakeholder providing input and feedback on health and safety-related design decisions, construction, and startup plans while ensuring decisions meet project deliverables and compliance requirements, leveraging existing Lilly knowledge, and incorporating external experiences and learning.
• Develop and roll out safety and health programs, procedures, tools, and overall HSE management systems, including training, mentoring, and onboarding of new staff to help support a strong HSE culture at the site.
• Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, assure safety and compliance of new systems, and assist in setting requirements to assure safe and compliant startup.

Post Startup

Program Development:

• Serve as a site key contact and HSE program expert, including knowledge of applicable corporate, local, state, and federal requirements and keeping abreast of changes to requirements and site applicability.
• Ensure applicable internal and external reporting is coordinated, completed, and submitted on time, including incorporating second person verification, as needed.
• Be a resource to the operational areas in helping them understand the regulatory requirements of their areas and programs; work with them in implementing solutions that comply with these regulations and programs.  Facilitate the implementation of the programs.
• Complete internal HSE audits/assessments, lead/support incident investigations, assist with trending HSE data and compiling metrics, and support the development of long-term plans to drive program improvements.
• Serve as liaison between site, regulatory agencies, and contractors (as related to program needs).
• Lead site emergency response team and provide guidance for site emergencies i.e., odor response and spill mitigation by working in conjunction with the Lilly Lebanon Incident Commander and Emergency Response Team.
• Participate in incident investigations, identification of root cause analysis/corrective and preventative actions for accidents, incidents and near misses.
• Participate in safety inspections/GEMBAs of operational areas with functional leaders and operational team members. Provide coaching and guidance on safety concerns and mitigation actions. 
• Maintain safety-related record keeping consistent with OSHA requirements.
• Participate in hazard reviews and ensure compliance with program elements and documentation for adequacy and completeness.

Additional Responsibility:

• Other areas of focus include safe manufacturing operations, chemical handling and storage, equipment isolation (lockout/tagout, line breaking), fire prevention (including hot work), confined spaces, and material handling,
• Oversight of environmental programs and compliance requirements. Responsible for performing all activities for environmental permit requirements.
• Oversight of GMP Manufacturing, QC Laboratory, Warehouse Operations, and Facilities
• Collaborate with key site partners (e.g., Global Health and Safety, Employee Health Services, API Network Manufacturing HSE teams) to standardize and improve effectiveness of HSE services across the sites.
• Lead and participate in governance meetings for safety driven programs and initiatives i.e., Safety committee meeting, laboratory safety team, ergonomic team
• Provide functional leadership and HSE program ownership to support the HSE management system and ensure compliance with relevant regulations and Lilly Global standards for HSE.
• Act as an agent of the company when interacting with regulatory and third-party officials representing the Company with appropriate care and diligence.
• Off Hour Support: 24/7 on call support for emergency response
• Off Hour Support: Availability for production support including nights, weekends, as needed.

Requirements:

• Bachelor’s degree in engineering or related science (e.g., chemistry, biology, occupational safety/health, industrial hygiene)
• 5+ years of experience in a manufacturing operations (preference for pharmaceutical or chemical)
• Experience applying Health and Safety regulations and developing Health and Safety programs

Additional Preferences:

• Excellent organization and time management skills, as well as strong analytical skills and systematic and structured way of working
• Strong collaboration and communication skills
• Ability to lead cross-functional and technical teams
• Experience interfacing with HSE-related regulatory agencies

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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