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Job Type:
Full-time

Industry:

Company: 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.

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 Gene Therapy 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.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

Main Purpose And Objectives Of Position

The Industrial Hygienist will serve as the Subject Matter Expert on Health and Safety matters and is responsible to ensure compliance for site operations at the Lilly Lebanon Gene therapy facility. This role is responsible for the development and oversight of the Industrial Hygiene programs and processes to maintain regulatory and corporate HSE standard compliance and provide support to functional site teams in a collaborative manner.

In the project delivery and startup phase of the project, 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 to a full scale GMP manufacturing through start up.

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 Industrial Hygiene 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 industrial hygiene related design decisions and startup plan while ensuring decisions meet project deliverables and compliance requirements.
  • Develop and adapt the HSE organizational structure where needed to provide correct and capable resources to support the site to full-scale GMP manufacturing.
  • Build technical relationships with the relevant corporate/global/Indianapolis departments and as needed and support strategic corporate initiatives at the site level.

Post Startup Program Development:

  • Manage the site industrial hygiene monitoring program and ensure it is compliant with regulatory requirements and Lilly Corporate Global Health and Safety Standards.
  • Develop, implement and sustain industrial hygiene and safety programs and associated trainings.
  • Develop and maintain adherence to the annual site industrial monitoring plan, maintaining an accurate record of results.
  • Participate in corporate and regulatory compliance audits and inspections; interact with regulators, auditors and customers during assessments; lead efforts to address gaps from these audits/inspections.

Business Support:

  • Evaluate and aid in the control of personnel exposure potential to chemical, physical, biological and ergonomic hazards encountered in the workplace through the use of appropriate tools, risk analysis techniques and assessments.
  • Perform assessments of new and continuous improvement processes and products and provide input on facility/equipment design safety control measures i.e., engineering controls and selection of PPE.
  • Participate in the review and approval of applicable change requests to ensure health and safety criteria are incorporated into the proposed modification.
  • Provide subject matter expert input to design, construct and maintain industrial hygiene related topics for site operations and functional team.
  • Perform industrial hygiene monitoring of various chemicals and processes and provide management with recommendations to reduce/eliminate employee exposures. Develop written reports for the above activities and track recommendations to completion. Communicate industrial hygiene monitoring results to employees and provide mentoring on the meaning of the results as needed.
  • Lead execution of site Industrial Hygiene Initiatives. Work in partnership with other functions at the site to advance IH initiatives in a collaborative manner.
  • 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 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 teams, 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

  • BS degree in Chemistry, Industrial Hygiene, Engineering or related science or engineering related discipline
  • 5+ years of directly related experience in a regulated industry (pharmaceutical or chemical manufacturing preferred) production environment

Additional Preferences

  • CIH preferred or currently pursuing certification.
  • Must have a strong ability to form effective relationships at all levels and build strong team cultures to ensure a safe and successful work environment.
  • Experience with implementing and managing industrial hygiene and occupational health and safety programs.
  • Must be capable of creating and communicating safety information to diverse audiences.
  • Proficiency using Microsoft products such as Word, Excel, and Powerpoint.

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.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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