Scientist-TS/MS-Cleaning Validation at Eli Lilly and Company

Carolina, Puerto Rico, Puerto Rico

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor’s or Master’s degree in scientific disciplines such as Chemistry, Engineering, or Chemical Engineering
3–5 years of experience in a cleaning validation program within a regulated pharmaceutical manufacturing environment
Additional relevant industrial experience in Engineering, Development, or Quality in Pharmaceutical or Protein Manufacturing Operations is desirable
Knowledge of cGMPs
Strong technical writing and presentation skills
Proficiency in process data analysis using statistical tools
Excellent interpersonal skills that foster engagement and teamwork in a cross-functional environment
Fully bilingual (English and Spanish)
Team-oriented with strong collaboration skills
Ability to influence and exercise sound judgment
Demonstrated leadership capabilities
Excellent oral and written communication skills
Ability to manage multiple assignments in a dynamic environment
Availability to support 24/7 operations

Responsibilities

Provide direct technical support to the cleaning validation program for fermentation and protein purification manufacturing processes
Serve as a subject matter expert (SME) for the Cleaning Control Strategy, including cleaning parameters and associated historical and potential failure modes, along with their countermeasures
Define and implement the routine process monitoring plan, ensuring alignment with the Cleaning Control Strategy to maintain process control and capability
Proactively detect changes in variability and identify/implement appropriate corrective actions
Lead the cleaning improvement agenda, translate cleaning process requirements, and educate Process Teams and operators
Design, review, and deliver Process School(s) at the start of each campaign, as applicable
Provide technical documentation of the cleaning program in official sources such as Process Flow Diagrams (PFDs), Quality Risk Assessments, manufacturing instructions, SOPs, and technical reports
Participate in the design and execution of Process, Cleaning, Bioburden Control Strategies, and Validation exercises
Ensure the cleaning process remains in a validated state through routine monitoring, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV), and Annual Product Reviews (APR)
Conduct investigations, develop CAPA plans, and present findings to the deviation board
Own and implement change controls effectively and in a timely manner
Collaborate with secondary loop personnel, TS/MS laboratory, other functions, and other Lilly manufacturing sites to identify and replicate best practices
Ensure data integrity and adherence to verification procedures
Provide technical support for cleaning processes related to new product introductions

Skills

Cleaning Validation

Fermentation

Protein Purification

Process Monitoring

Quality Risk Assessment

SOP

Process Flow Diagrams

Bioburden Control

Validation

SME

Technical Documentation

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