Maintenance Director Manufacturing Jobs in Indiana

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.

For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

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.

The Manufacturing Operator will be responsible for performing routine manufacturing activities across GMP manufacturing areas, including: Cell Culture, Downstream Purification, and Fill & Finish at the Lebanon Advanced Therapies, LP2 site.

Initially, the Operator will be responsible for supporting execution of equipment qualification, developing site operations procedures and setting up production areas. During this initial project delivery/startup phase of the project, roles will be fluid and dynamic. Once the plant is operational, the Manufacturing Operator will be responsible for execution of production activities on their shift under the leadership of the shift supervisor.

As a Manufacturing Operator, your responsibilities will include:

• Work in a cleanroom environment to produce advanced therapies in a safe and quality manner.
• Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of advanced therapies.
• Participate in equipment commissioning and qualification testing and process validation activities in collaboration with other departments.
• Safely work with BSL-2 materials, following site biologics safety program.
• Conduct and appropriately document production of advanced Therapies via strict adherence to digital manufacturing batch records and affiliated SOPs.
• Utilize and monitor manufacturing equipment to ensure performance and safety standards are met.
• Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.
• Provide verbal and written reports to supervisors and other teams in a clear and concise manner.
• Maintain accurate and complete electronic records and logbooks as per cGLP and/or cGMP, as appropriate.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
• Compliance with cleanroom gowning requirements required for completing specific work in drug substance and drug product.

• Work well in a fast-paced team environment.

Minimum Requirements:

• High School diploma or equivalent
• Direct manufacturing experience with automatic, manual, and semi-automated equipment, following operational procedures.
• 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:

• 3+ years pharmaceutical cleanroom experience or equivalent comparable manufacturing experience
• Drug Substance experience; hands-on expertise working with bioreactors, sums, TFFs, purification, and similar processes
• Technical problem-solving skills.
• Good communications skills (both oral and written).
• Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
• Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
• Good organization skills.
• Ability to work with and learn new digital systems
• Ability to demonstrate attention to detail

Other Information:

• During the start-up phase of the project, the shift will be primarily day shift. As the site nears normal operation, shift work will be required. Anticipated to be 4 x 10 hour rotating shifts
• Ability to maintain focus on a complex task for 4-6 hours at a time.
• Adaptable to work in a fast-paced and evolving environment.
• Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties.
• Some overtime required.