Senior/ Principal Process Engineer - API 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

Pharmaceuticals, HealthcareIndustries

Requirements

Technical leadership and expertise in API process engineering
Experience with unit operation control and statistical thinking for process performance monitoring and engineering decisions
Knowledge of FUME assessment for operational control strategy risks
Experience with equipment specification, procurement, and IQ/OQ/PQ
Familiarity with HSE and PSM elements impacting products at contract manufacturers (CMs)
Ability to develop and sustain process knowledge (e.g., material/energy balances, kinetics, chemistry, process modeling, equipment design basis)
Proficiency in optimization resources/tools for process analysis and improvement
Experience with root cause analysis, countermeasure development, and incident investigations
Adherence to Lilly Red Book expectations for interactions with CMs
Capability to coach, mentor, and peer review process team members and documentation

Responsibilities

Coach and mentor process team members, providing insight and feedback to Lilly/CM Joint Process Team (JPT)
Champion statistical thinking and data use for process performance monitoring and decisions
Support and peer review root cause analysis for FUME and operational incidents
Peer review documentation of learning points, technical studies, and incident investigations
Identify process knowledge gaps impacting equipment/process capability
Develop/support capture of key process knowledge and maintain infrastructure (e.g., models, report history, lab models, literature)
Utilize optimization tools for process analysis and improvement studies
Review and track key process engineering metrics
Identify systemic issues affecting production and reliable supply from CMs
Lead/participate in root cause analysis and countermeasure implementation for safety, quality, or throughput incidents
Review/approve documentation and engineering decisions
Conduct practice vs. procedure walk-throughs and housekeeping/fit & finish walk-throughs at CM sites
Support development and technical analysis for continuous improvement activities
Review/identify cost reduction opportunities, process capacities, and bottlenecks
Assist in prioritizing opportunities aligned with business objectives
Work with CMs to apply statistical methods for process variability/capability
Perform/promote optimization of unit operation cycle time, loading, and yield
Engage with internal/external resources on new/evolving technologies impacting portfolio assets
Direct/indirect interaction with CM personnel for reliable supply via operational control strategy execution
Participate in assessing HSE/PSM elements at CMs impacting Lilly products

Skills

Process Engineering

API Manufacturing

Unit Operations

Control Strategy

FUME Assessment

IQ/OQ/PQ

Equipment Specification

HSE

PSM

Contract Manufacturing

Process Knowledge

Technical Leadership

Risk Assessment

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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