Senior/Principal Scientist Validation at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Degree in engineering, pharmacy, or equivalent with at least 5 years of professional experience in the industry
Knowledge of GMP
Operation skills
Good knowledge of document and project management
German and basic English knowledge
Additional preferences: Parenteral manufacturing experience, strong analytical and synthesis skills, excellent interpersonal and communication skills, ability to work independently and in a team, ability to coordinate teams without direct hierarchical power

Responsibilities

Instruct and support the validation of production equipment and systems
Perform sterilization validation, cleaning validation, filter validation, shipping validation, process validation, and other TS/MS related activities
Prepare, review, and support relevant technical documents, such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, and procedures
Participate in development and implementation of process functional teams to implement TS/MS objectives and deliver on business and quality objectives
Initiate related validation protocols and reports, and coordinate validation related activities
Complete required and assigned trainings on-time
Ensure compliance with final objectives and coordinate with local project team

Skills

Key technologies and capabilities for this role

Sterilization ValidationCleaning ValidationEquipment ValidationSystem ValidationPharmaceutical Production

Questions & Answers

Common questions about this position

What is the location for this Senior/Principal Scientist Validation role?

The position is based at Lilly's new high-tech production facility in Alzey, Rhineland-Palatinate, Germany.

What are the key responsibilities in this validation scientist role?

Responsibilities include instructing and supporting validation of production equipment and systems, such as sterilization validation, cleaning validation, filter validation, shipping validation, and process validation, as well as preparing and reviewing technical documents like validation protocols, reports, change controls, and deviation investigations.

What qualifications are required for this position?

Candidates need a degree as an engineer, pharmacist, or equivalent, along with qualifying certifications, training, or experience.

What are Eli Lilly's core values mentioned for this role?

The three Lilly values are 'Excellence,' 'Integrity,' and 'Respect for People.'

What makes a strong candidate for the Senior Principal Scientist Validation role?

A strong candidate will have a degree in engineering, pharmacy, or equivalent, experience in validation activities like sterilization, cleaning, and process validation, and the ability to prepare technical documents and ensure compliance with quality objectives.

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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