Principle Process Engineer - API EM at Eli Lilly and Company

Indianapolis, Indiana, United States

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$64,500 – $167,200Compensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Process knowledge
Equipment suitability assessment
CM personnel interaction
Operational control strategy execution
FUME assessment
Equipment specification, procurement, and IQ/OQ/PQ participation
HSE and PSM element assessment
New/evolving technology application
Adherence to the Lilly Red Book expectations

Responsibilities

Develop and sustain process knowledge to ensure the execution of the appropriate product, process, and operational control strategy at contract manufacturers (CMs)
Assess the suitability of proposed equipment sets to ensure success of process validations
Direct and indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy
FUME assessment to ensure an understanding of risk presented to the operational control strategy
Participation with internal or CM resources in the equipment specification, procurement, and IQ/OQ/PQ
Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products
Engaged with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets
Coach and Mentor Process Team Members
Utilize past experiences with unit operation control to provide insight and feedback to members of the CM Joint Process Team (JPT)
Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT
Support and peer review root cause analysis around FUME and operational incidents
Peer review documentation of learning points, technical studies, and incident investigations

Skills

Key technologies and capabilities for this role

Synthetic Peptide SynthesisPeptide PurificationSmall Molecule ProcessingProcess KnowledgeEquipment Suitability AssessmentIQ/OQ/PQHSEPSMFUME AssessmentOperational Control StrategyContract Manufacturing

Questions & Answers

Common questions about this position

What is the salary range for this Principal Process Engineer position?

The salary range is $64,500 - $167,200, with actual compensation depending on a candidate’s education, experience, skills, and geographic location.

Is this position remote?

Yes, this is a remote position.

What key skills and expertise are required for this role?

Required skills include process knowledge, equipment suitability assessment, CM personnel interaction, operational control strategy execution, FUME assessment, equipment specification and IQ/OQ/PQ participation, HSE and PSM element assessment, and new/evolving technology application.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, putting people first, giving best effort to work, and engaging in philanthropy and volunteerism.

What makes a strong candidate for this Principal Process Engineer role?

Strong candidates will have deep process knowledge, experience with equipment assessment and specification including IQ/OQ/PQ, expertise in FUME and HSE/PSM assessments, and the ability to coach teams and apply statistical thinking at contract manufacturers.

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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