Scientist – Cleaning and Contamination Control, Process Translation & Execution, Clinical Trial API Manufacturing
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Lebanon • 🇺🇸 United States
Visit company websiteSalary
💰 $66,000 - $171,600 per year
Job Level
Mid-LevelSenior
About the role
- Design and develop the Foundry’s cleaning strategy and drive implementation of the site cleaning program
- Define equipment sets, characterize product groups, select appropriate cleaning agents and cycles, and conduct recovery and cleanability studies to ensure effective and compliant cleaning processes
- Establish cleaning acceptance criteria/carryover limits and collaborate with the analytical laboratory to ensure that analytical methods are appropriate to mitigate risk and maintain patient safety
- Develop and maintain site Standard Operating Procedures (SOPs), policies, and standardized cleaning documentation to ensure regulatory compliance, operational consistency, and adherence to industry best practices
- Support the development and ongoing execution of a cleaning and inspection training program for the Foundry
Requirements
- BS or MS in Chemistry, Biology, Biochemistry, Chemical/Biological Engineering, or related disciplines
- BS with 5 years or MS with 3 years experience in qualification/validation of GMP facilities and process equipment in a pharmaceutical/biopharmaceutical facility
- Knowledge of equipment cleaning lifecycle approach and regulatory requirements
- Strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner within a GMP environment
- Proficient in MS Office (Word, Excel, Project, Outlook, etc.)
Benefits
- Company bonus (depending, in part, on company and individual performance)
- Eligibility to participate in a company-sponsored 401(k)
- Pension
- Vacation benefits
- Eligibility for medical, dental, vision, and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
cleaning strategy designcleaning program implementationequipment characterizationcleaning agent selectioncleanability studiescleaning acceptance criteriaanalytical methodsStandard Operating Procedures (SOPs)regulatory compliancequalification/validation of GMP facilities
Soft skills
strong communication skillsoral communicationwritten communicationtechnical information presentation