Senior / Principal Process Engineer - APIEM at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Technical leadership and expertise in process engineering
Experience in conjunction with API EM contract manufacturer personnel
Understanding of process knowledge and operational control strategy
Familiarity with equipment specification, procurement, and IQ/OQ/PQ
Knowledge of HSE and PSM elements
Ability to engage with internal and external resources in developing capabilities with new or evolving technologies
Adherence to the expectations of the Lilly Red Book

Responsibilities

Developing and sustaining process knowledge to ensure the execution of the appropriate product, process, and operational control strategy at contract manufacturers (CMs)
Direct and indirect interaction with CM personnel to ensure reliable supply via CM execution of the operational control strategy
Conducting FUME (First Unit Operation Monitoring Evaluation) assessments to understand risk related to the operational control strategy
Participating with internal or CM resources in equipment specification, procurement, and IQ/OQ/PQ
Participating with internal and CM resources to assess the HSE (Health, Safety, and Environment) and PSM (Process Safety Management) elements of the CM that impact Lilly products
Engaging with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets
Coaching and mentoring Process Team Members, utilizing past experiences with unit operation control to provide insight and feedback to members of the Lilly / CM Joint Process Team (JPT)
Championing the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT
Supporting and peer reviewing root cause analysis around FUME and operational incidents
Peer reviewing documentation of learning points, technical studies, and incident investigations
Developing and sustaining process knowledge, identifying process knowledge gaps, and developing or supporting the capture of key process knowledge (examples include material and energy balances, kinetics, process modeling, and equipment design basis)
Utilizing optimization resources and tools for process analysis and process improvement studies
Reviewing and tracking key process engineering metrics
Providing Process & Equipment Support, identifying systemic issues affecting process performance

Skills

Process Engineering

IQ/OQ/PQ

HSE

PSM

Equipment Specification

Procurement

Operational Control Strategy

Contract Manufacturing

FUME Assessments

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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