Director - Commissioning and Qualification at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor’s degree in engineering, related science or Project Management, or a related field
Minimum of 10 years of experience in commissioning and qualification activities within the pharmaceutical or biotech industry
Preferred Qualifications
Proven track record of managing large-scale C&Q programs from design phase through to closeout and handover
Strong knowledge of ASTM E2500 Model and Verification methodology
Excellent leadership, communication, and organizational skills
Ability to work effectively in a cross-functional team environment
Experience with major site projects and pharmaceutical & process safety processes
Familiarity with regulatory requirements and industry standards for commissioning and qualification
Certification in project management (PMP or equivalent) is a plus

Responsibilities

Lead the development of effective global safety programs from procedure development, delivery training and coaching to transfer the knowledge to the project CQV leader for execution in the field during project
Develop and ensure implementation of comprehensive C&Q strategies for major capital projects, including parallel commissioning of multiple production facilities and support buildings in a GMP and process safety regulated environment
Create guidance that will transfer to the project C&Q lead to managing the development of CQ strategies and execution plans, schedule, and budget to ensure timely and cost-effective delivery
Provide technical oversight and guidance to the C&Q team, ensuring adherence to industry standards and best practices
Coordinate with project C&Q Leaders and teams to assess, provide direction, and oversee the implementation of engineering and construction services
Ensure guidance for the development and maintaining traceability matrices to demonstrate how commissioning testing met user requirements
Develop guidance and work hand-to-hand with project C&Q organization to support schedule and deliver to budget in collaboration with the Process Equipment COE and other key professional services to maintain a diverse and capable pool of service providers
Monitor and understand market conditions to educate and influence project decisions with current data

Skills

Commissioning

Qualification

CQV

GMP

Process Safety

Regulatory Compliance

Project Management

Safety Programs

Procedure Development

Training

Coaching

Technical Oversight

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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