Manufacturing Associate
Healthcare
ManufacturingAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Manufacturing Associate at Manufacturing Associate. Skills: Advanced therapies, GMP manufacturing. Perform routine manufacturing activities. Support equipment qualification”
What You'll Achieve.
Improvements in safety; Improvements in quality; Process performance improvements
Industry & Context.
Technical problem-solving
Shift work required, Rotating shifts, Overtime required
What They're Looking For.
Must Have
Bachelor's degree in STEM, High school diploma + 5 years pharmaceutical manufacturing experience, Authorized to work in US full-time
Nice to Have
Direct manufacturing experience, Technical problem-solving skills, Good communications skills, Learning GMP regulations, Adhere to safety guidelines, Good organization skills, Ability to learn new digital systems, Attention to detail
What You'll Do.
Perform routine manufacturing activities
Support equipment qualification
Develop site operations procedures
Set up production areas
Execute production activities
Work cross functionally with TSMS
Establish operational controls
Produce advanced therapies safely
Coordinate production activities
Facilitate on-time release
Participate in commissioning testing
Participate in qualification testing
Participate in process validation
Work with BSL-2 materials
Follow site biologics safety program
Document production of advanced therapies
Adhere to digital manufacturing batch records
Adhere to affiliated SOPs
Utilize manufacturing equipment
Monitor manufacturing equipment
Ensure performance standards met
Ensure safety standards met
Collaborate with maintenance technicians
Collaborate with equipment manufacturers
Collaborate with quality assurance
Ensure production equipment in good order
Ensure production equipment validated
Provide verbal reports to supervisors
Provide written reports to supervisors
Maintain electronic records
Adhere to applicable procedures
Adhere to company policies
Adhere to quality requirements
Adhere to regulatory requirements
Comply with cleanroom gowning
Work in fast-paced team environment
How You'll Work.
Team & Collaboration
Cross functional teams; Quality Control; Quality Assurance; Plant Maintenance; Maintenance technicians; Equipment manufacturers; Quality assurance
Communication Scope
Verbal reports; Written reports
Process & Methodology
Project delivery, Startup phase
Full Job Description
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. **Position Overview:** The Manufacturing Associate 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 Manufacturing Associate 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 Associate will be responsible for exe
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