Senior Engineer, Quality Assurance - FUME at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

(Details are missing from the provided text. Further information would be needed to list specific requirements.)

Responsibilities

Maintains responsibility for a safe work environment, leading safety initiatives, and working safely
Accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals
Leads, mentors, and coaches operations and support personnel on FUME (Facilities, Utilities, Maintenance, and Equipment) quality matters
Acts as a QA Subject Matter Expert (SME), collaborating with Global Facilities Delivery, Lilly project staff, Global Computer Systems QA, and selected service provider firms
Provides technical and quality review and approval of facility, utility, and equipment system documents, ensuring compliance with Lilly Global Quality Standards and project/local quality procedures
Provides quality oversight for the verification and qualification of facility, utility, and equipment systems, including review of test cases, test execution, test summaries, and discrepancy resolution
Provides QA oversight of maintenance activities, including initial calibrations and maintenance plan development

Skills

Quality Assurance

FUME

Facilities Management

Utilities Management

Maintenance Planning

Equipment Qualification

System Verification

Test Execution

Discrepancy Resolution

Calibration

GMP Compliance

Safety Leadership

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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