HSE Permit Writer - Lilly Medicine Foundry

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

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), operational 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. 

Position Overview:

The Lilly Medicine Foundry Health Safety and Environment (HSE) Permit Writer actively supports start-up activities to bring manufacturing equipment into service. The Health Safety and Environment (HSE) Permit Writer will develop and maintain safe work permits within the production area. A successful candidate will interface with the Process Team and Project Team to manage equipment availability.

This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs. In the pre-startup phase, the HSE Permitter will contribute heavily to Operational Readiness preparations for the new facility, such as creation of trainings, procedures, and workflows to support future Foundry needs and operating plans.

Responsibilities:

An HSE Permitter ensures that all necessary permits are accurately prepared and issued for various work activities. They play a crucial role in maintaining compliance with safety regulations by conducting thorough risk assessments, developing safety plans, and auditing live work permits. To excel in this role, they must exhibit meticulous attention to detail, effective problem-solving abilities, excellent communication skills, a solid understanding of technical hazards, and strong organizational skills. In line with the job outlined above, the following are typically the key tasks that would be expected of the role:

• Safe work permit preparation including the coordination of operations, project, and maintenance personnel.
• Execute the required safe work permits, which includes but is not limited to lock out tag out (LOTO), hot work, confined space entry, etc.
• Develop equipment specific lock-out, tag-out, try procedures.
• Develop confined space entry risk assessments.
• Develop and maintain permitting equipment and supplies. 
• Perform safety audits and maintain an audit ready status.
• Review and monitor relevant Standard Operating Procedures (SOPs) and SOP updates. Execute unplanned SOP changes.
• Influence adherence to project and maintenance schedules.
• Lead departmental improvement projects related to safety, LOTO practices, 5S, equipment maintainability and accessibility, ergonomic improvements, etc.
• Support Process Engineers/Maintenance/Projects and Supervision in daily operations.
• Identify and support the implementation of improvements from Operations.
• Own the issuance of non-routine work instructions with input from Process Chemists/Process Engineers.
• Ownership of daily tasks, preventative maintenance or breakdowns.
• Conduct continuous improvement projects which are aligned with safety and quality expectations and meet operational needs.
• Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards.
• Understand other area processes & their operational hazards and being able to react appropriately.
• Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects.
• Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.  

Basic Requirements:

• HS Diploma/GED
• 5+ years of directly applicable bulk API (active pharmaceutical ingredient) manufacturing experience, GMP and/or chemical processing strongly preferred.
• Previous experience in a pharmaceutical or chemical manufacturing operation involving PSM-regulated or hazardous chemicals.
• Experience coordinating maintenance, LOTO, and/or piping change activities in a GMP production environment.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences:

• Previous experience in facility or area start-up environments.
• A solid understanding of FDA guidelines and cGMP requirements.
• Strong organizational skills with the ability to handle and prioritize multiple requests.
• Knowledge of lean manufacturing principles.
• Flexibility to troubleshoot and triage challenges effectively.
• The ability to understand technical nomenclature and language, as well as work with mathematical formulas.
• Ability to effectively communicate (electronically, written, and verbally).
• Basic computer skills (desktop software) are required.

Additional Information:

• Position Location: US: Lebanon IN Lilly Medicine Foundry Operations initial location in Indianapolis, IN during pre-startup phase
• Travel Percentage: 5%
• The HSE Permit Writer role operates on a work schedule of Monday through Friday, 8 hours per day. The job may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend training activities etc. Flexibility in work schedules and the ability to work overtime as needed are essential. 
• Position requires on-site presence on a M-F schedule, with flexibility to support activities in a 24-hour manufacturing environment during shutdowns, weekends, etc. 

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’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

$28.84 - $46.54

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.

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