QA Engineer, Foundry at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor of Science Degree in Engineering or related field (e.g. biology, chemistry, computer science, etc.)
Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.)

Responsibilities

Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations
Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements
Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts
Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets including review and approval of associated deliverables (protocols, drawings, test documents, etc.)
Influence and oversee Maintenance/Calibration programs within the Foundry, including benchmarking with other Lilly sites
Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA)
Escalate and/or initiate notification to management for departures of critical nature and assure issues are addressed appropriately
Ensure the Foundry is audit ready at all times and participate in internal/external inspections

Skills

Key technologies and capabilities for this role

cGMPQuality AssuranceGMP ComplianceRegulatory ComplianceFacilities ManagementUtilities ManagementEquipment QualificationComputer Systems ValidationManufacturing OversightProcedure Review

Questions & Answers

Common questions about this position

What is the employment type for this QA Engineer position?

The position is full-time employment.

Is this QA Engineer role remote or on-site?

This information is not specified in the job description.

What are the basic educational requirements for the QA Engineer role?

A Bachelor of Science Degree in Engineering is required.

What does the team structure look like for the Foundry QA Engineer?

This role is part of a team supporting the design, construction, and qualification at the Foundry as this new manufacturing site is built at a green field site.

What experience makes a strong candidate for the QA Engineer position at the Foundry?

Strong candidates should have expertise in cGMP compliance, Commissioning and Qualification (C&Q), Computer Systems Validation (CSV), and evaluating GMP-related incidents with root cause analysis.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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