Operator/Sr Operator/Expert Operator - Manufacturing

BioSpace; Lebanon (IN); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking dedicated Manufacturing Operators to join a greenfield team in Lebanon, Indiana. This exciting role involves producing advanced therapies while adhering to rigorous quality standards and safety protocols. As part of a startup initiative, you will engage in equipment qualification, operational procedure development, and production activities in a fast-paced environment. Ideal candidates will possess strong problem-solving and communication skills, along with a commitment to safety and quality. If you're ready to make a significant impact in the healthcare sector, this opportunity is perfect for you.

Qualifications

• Experience with manufacturing equipment and GMP regulations.
• Strong communication and problem-solving skills are essential.

Responsibilities

• Produce advanced therapies in a cleanroom environment.
• Coordinate with Quality Control and Assurance for product release.
• Document production activities accurately according to SOPs.

Skills

Problem-solving skills

Strong communication skills

Organizational skills

Attention to detail

Ability to learn digital systems

Education

High School diploma or equivalent

Tools

Manufacturing equipment (automatic, manual, semi-automated)

Job description

Operator/Sr Operator/Expert Operator - Manufacturing

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Operator/Sr Operator/Expert Operator - Manufacturing

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Join to apply for the Operator/Sr Operator/Expert Operator - Manufacturing role at BioSpace

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 work worldwide to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We put people first and strive for excellence in our work.

Lilly has a 140-year history of manufacturing medicines that improve lives globally. We utilize advanced manufacturing technologies and maintain rigorous quality standards. Our new facility in Lebanon, Indiana, dedicated to innovative modalities including Gene Therapy, will feature next-generation technologies and data platforms to enhance safety, quality, and performance. This presents a unique opportunity to be part of a startup team for a greenfield manufacturing site, supporting both clinical and commercial supply.

The Manufacturing Operator will perform routine activities across GMP manufacturing areas such as Cell Culture, Downstream Purification, and Fill & Finish at the Lebanon Advanced Therapies, LP2 site.

Initially, responsibilities include supporting equipment qualification, developing operational procedures, and setting up production areas. Once operational, the role involves executing production activities during shifts under supervision.

Your Responsibilities Will Include:

• Working in a cleanroom environment to produce advanced therapies safely and with high quality.
• Coordinating with Quality Control, Quality Assurance, and Maintenance for timely release of products.
• Participating in equipment commissioning, qualification, and process validation activities.
• Handling BSL-2 materials following biosafety protocols.
• Documenting production activities accurately according to batch records and SOPs.
• Monitoring equipment performance and safety.
• Collaborating with maintenance and QA teams to ensure equipment validation and readiness.
• Providing clear verbal and written reports.
• Maintaining electronic records compliant with cGLP/cGMP standards.
• Adhering to all procedures, policies, and regulations.
• Following gowning requirements for work in drug substance and drug product areas.
• Working effectively in a fast-paced team environment.

Minimum Requirements: High School diploma or equivalent

Additional Preferences:

• Experience with manufacturing equipment (automatic, manual, semi-automated).
• Problem-solving skills.
• Strong communication skills.
• Understanding of GMP regulations and adherence.
• Commitment to safety and environmental standards.
• Organizational skills and attention to detail.
• Ability to learn digital systems.

Other Information:

• During startup, primarily day shifts; later, rotating shifts (4x10 hours).
• Ability to focus on complex tasks for 4-6 hours.
• Adaptability to a dynamic environment.
• Effective communication with team members.
• Some overtime may be required.

Lilly is committed to accommodating individuals with disabilities. For assistance with the application process, please complete the workplace accommodation request form. Lilly is an EEO employer, promoting diversity and equal opportunity in the workplace.