Tech@Lilly CSV Analyst - Lilly Medicines Foundry at Eli Lilly and Company

Lebanon, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Technical leadership in Computer Systems Validation (CSV) across IT groups
Knowledge of external regulations, industry best practices, policies, and procedures for validating, maintaining, and retiring computer systems
Ability to define and maintain CSV local policies and procedures aligned with enterprise policies and regulatory requirements
Collaboration skills with Lilly Tech@Lilly, Quality organizations, and external industry forums/standards
Oversight and support for CSV activities, including review and approval of validation/qualification documentation for non-GMP and GMP systems
Expertise in risk management for CSV, including application of Computer Software Assurance principles
Experience acting as primary contact for internal/external CSV audits, privacy inspections, and GMP-related systems in collaboration with Computer Systems Quality Assurance
Knowledge of privacy initiatives to ensure compliance with internal/external privacy policies
Support for Data Integrity readiness for regulatory inspections and ability to represent the company during audits related to data management and integrity
Ability to anticipate short-term and future CSV needs

Responsibilities

Provide CSV technical leadership across IT groups in Lilly Medicines Foundry, focusing on regulations, best practices, policies, and procedures for computer systems
Define and maintain CSV local policies and procedures to ensure solutions are developed and implemented per enterprise policies and regulatory requirements
Collaborate with Lilly Tech@Lilly, Quality organizations, and external forums to maintain compliance of computer systems
Provide oversight and support for computer systems validation activities, including review and approval of documentation for non-GMP and GMP systems
Provide input and execute risk management approach for CSV at Lilly Medicine Foundry sites, applying Computer Software Assurance principles
Act as primary contact for internal/external CSV audits, privacy inspections, and GMP systems, collaborating with Computer Systems Quality Assurance
Lead privacy initiatives to ensure computer-based systems comply with policies and requirements
Support Data Integrity readiness for regulatory authority inspections at Lilly Medicine Foundry
Represent the company during regulatory audits through interactions with officials on data management and integrity

Skills

Key technologies and capabilities for this role

CSVData AnalysisPharmaceutical ManufacturingClinical Trial SuppliesAPIGMP

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working on-site?

This information is not specified in the job description.

What are the main responsibilities of the Tech@Lilly CSV Analyst role?

The role provides CSV technical leadership across IT groups in the Lilly Medicines Foundry, defines and maintains CSV local policies and procedures, ensures solutions meet enterprise policies and regulatory requirements, and collaborates with Lilly Tech@Lilly, Quality organizations, and external industry forums.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, gives best effort to work, and seeks determined individuals; they emphasize philanthropy, volunteerism, and delivering innovative medicines.

What makes a strong candidate for this CSV Analyst position?

Strong candidates will have expertise in computer systems validation (CSV), knowledge of regulations, industry best practices, and the ability to provide technical leadership, define policies, and collaborate across IT, Quality, and external forums.

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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