Engineer - TS/MS Device Assembly & Packaging, DPEM at Eli Lilly and Company

Indianapolis, Indiana, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Be or become the process expert for process steps or processing equipment in Device Assembly and Packaging, including understanding the purpose, science, entire process, control strategy, key process parameters, critical quality attributes, historic and potential failure modes, product process history, development, and validation history
Understand scientific principles required for Device Assembly and Packaging Operations

Responsibilities

Support on-going CM operations by providing technical oversight at the Joint Process Team as Primary Loop support
Translate process requirements and education to Joint Process Team members
Document work and learnings in an official source such as Process Flow Diagrams
Participate in the design and execution of process, cleaning, sterility, and Bioburden control strategies and validation processes (PV/PPQ), and oversee associated documentation
Provide oversight to any PQ activity at the CMs, with holistic understanding of process, equipment, facilities, computer systems, and operations
Ensure accurate process flow diagram describing the process, control strategy, process parameters, and critical quality attributes
Ensure process remains in a validated state through routine monitoring
Ensure timely completion of annual product reviews (APRs) and Ongoing Process Verification (OPV), with action plans defined and monitored for control, capability, and continuous improvement
Assist Quality and Supply Chain personnel in timely completion of SCR, Quality Agreement, and MRDs as necessary
Assist CMs in preparation for audits from Lilly (GQAAC) or external agencies impacting Lilly products
Use statistical tools to understand and reduce sources of variability and continuously improve the process
Use data history and other sources to extract relevant process parameters
Lead process rel (incomplete in description)

Skills

Device Assembly

Packaging

Manufacturing Science

Technical Service

Process Oversight

Contract Manufacturing

Joint Process Team

Process Expertise

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.

Land your dream remote job 3x faster with AI

Try Jobo Free