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Lilly QC Scientist - Analytical Equipment Support in Lebanon, 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.

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 35,000 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 an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Position Description:

The Analytical Equipment Support Group (AESG) Scientist provides technical leadership and expertise for analytical instrumentation in the areas of: Coaching and Mentoring AESG personnel, continuous improvement, equipment capability and adherence to business systems. The Scientist completes technical review of protocols and reports and shares technical information and best practice within the group.

Key Objectives/Deliverables:

  • Manage comprehensive equipment life-cycle management.

  • Provide oversight to Project Teams during implementation of significant capital projects in LP1.

  • Represent LP1on Global Lab Equipment Network.

  • Review and approve documents supporting computerized systems and validations including, procedures, observations, periodic reviews and change proposals.

  • Adhere to global quality standards related to computer systems.

  • Identify systemic issues affecting analytical testing in QC.

  • Research and recommend new technologies.

  • Serve as a technical mentor for Scientists and Technicians both within and outside QC.

  • Coordinate/Benchmark with both internal and external organizations in instrument selection, usage, and troubleshooting.

  • Coordinate with lab SMEs for procurement, set-up, and validation of correct lab equipment.

  • Create maintenance work instructions.

  • Manage the drafting and review of cGMP documents.

  • Provide technical review and approval of documentation.

  • Manage/Develop maintenance strategies.

  • Participate in self-assessments and regulatory inspections/audits.

  • Provide technical review and Second Person Verification (SPV).

  • Lead investigations.

  • Author qualification protocols and ensure alignment to quality systems.

  • Maintain and improve quality systems.

  • Troubleshoot equipment and methods as required.

  • Provide technical support to non-routine (e.g., observations) investigations including the preparation as required of relevant technical documents, such as: Change Controls, Analytical Investigations, Validation Protocols, Procedures and Quality System Management Review, etc.

Basic Requirements:

  • Bachelor’s degree in a relevant field (chemistry or engineering is preferred).

  • 2+ years of work experience in an engineering, maintenance, or technical support area.

Additional Preferences:

  • Demonstrated strong problem solving and analytical troubleshooting skills.

  • Understanding of statistical tools and analysis.

  • Excellent interpersonal skills and networking skills.

  • Strong computer skills (GMARS, TrackWise, Empower, Quality Docs, etc.).

  • Ability to organize and prioritize multiple tasks.

  • Demonstrated strong written and verbal communication skills.

  • Recognized by others as having technical expertise of analytical equipment functionality.

  • Demonstrate scientific and technical expertise.

  • Teamwork and interpersonal skills.

  • Decision making.

  • Multi-tasking.

  • Ability to prioritize.

  • Ability to influence others.

  • Attention to details.

  • Written and oral communication skills.

  • Complex instrumentation problem solving.

  • Mentoring/leadership.

  • Self-motivation.

  • Clear understanding of all cGMP and GQS, polices, procedures and guidelines.

Other Information:

  • May require working off hours to address urgent business needs.

  • Tasks require entering laboratory and manufacturing areas which require wearing appropriate PPE.

  • Tasks may require repetitive motion and standing for long periods of time.

  • Task may require working in areas containing allergens and other potentially hazardous materials.

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 ( LillyRecruitingCompliance@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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