Sr. Principal – Scientist - (QC - Lab Informatics)
Eli Lilly and Company
5 hours ago
On-site
Houston, TX
$65,250 - $169,400 USD yearly
IT
Position Description
- Monitor laboratory performance to maintain control over the generation and reporting of analytical data.
- Initially work with global/local IT to populate master data, configure systems, and install/qualify lab IT systems (LIMS/LES LabVantage, MODA, WinKQCL, ELN NuGenesis, CDS Empower, and other lab systems).
- Evolve to monitoring, execution, maintenance, and continuous improvement of QC Laboratory IT systems with emphasis on data integrity.
- Serve as an SME for laboratory IT systems; mentor/educate peers on lab system use.
- Support audits and inspections; provide oversight for management reviews and laboratory metrics/equipment/documentation.
Key Objectives
- Validate laboratory equipment and software systems.
- Support establishment and maintenance of validated software-based computerized systems.
- Ensure data integrity by design.
- Assist with site deployment and upgrades of QC Laboratory IT systems.
- Partner with Global Quality Laboratory Network and global/site IT teams.
- Collect data and author management review documents for the laboratory quality system.
- Apply quality principles, cGMP, and lab systems to procedures, training, and practices.
- Improve quality systems via worksheets, documentation updates, method updates, and other lab documentation.
- Implement and comply with corporate/site/lab safety standards.
- Develop training materials for laboratory informatics systems.
Basic Requirements
- Bachelor’s degree in computer science, information systems, chemistry, microbiology, biology, or another relevant field.
- 3+ years’ GMP QC Laboratory IT systems experience (installation/qualification, master data population, and system configuration).
Additional Skills/Preferences
- Strong understanding of compliance and regulatory expectations.
- Demonstrated accuracy and proficiency in analytical skills.
- Proficiency with Microsoft Office, LIMS, Laboratory Execution Systems, chromatography systems, and electronic laboratory notebook systems.
- Ability to work in a lab environment with appropriate PPE.
- Excellent written and oral communication skills.
- Previous LEAN experience.
- Experience operating/implementing Lab IT systems (e.g., LIMS and automated lab execution systems).
- Cross-functional leadership experience using problem-solving and decision-making.
Benefits
- Company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life insurance/death benefits; time off/leave benefits; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Application Instructions
- Qualified applicants must be authorized to work in the United States full-time; Lilly does not sponsor work authorization/visas.
- Monitor laboratory performance to maintain control over the generation and reporting of analytical data.
- Initially work with global/local IT to populate master data, configure systems, and install/qualify lab IT systems (LIMS/LES LabVantage, MODA, WinKQCL, ELN NuGenesis, CDS Empower, and other lab systems).
- Evolve to monitoring, execution, maintenance, and continuous improvement of QC Laboratory IT systems with emphasis on data integrity.
- Serve as an SME for laboratory IT systems; mentor/educate peers on lab system use.
- Support audits and inspections; provide oversight for management reviews and laboratory metrics/equipment/documentation.
Key Objectives
- Validate laboratory equipment and software systems.
- Support establishment and maintenance of validated software-based computerized systems.
- Ensure data integrity by design.
- Assist with site deployment and upgrades of QC Laboratory IT systems.
- Partner with Global Quality Laboratory Network and global/site IT teams.
- Collect data and author management review documents for the laboratory quality system.
- Apply quality principles, cGMP, and lab systems to procedures, training, and practices.
- Improve quality systems via worksheets, documentation updates, method updates, and other lab documentation.
- Implement and comply with corporate/site/lab safety standards.
- Develop training materials for laboratory informatics systems.
Basic Requirements
- Bachelor’s degree in computer science, information systems, chemistry, microbiology, biology, or another relevant field.
- 3+ years’ GMP QC Laboratory IT systems experience (installation/qualification, master data population, and system configuration).
Additional Skills/Preferences
- Strong understanding of compliance and regulatory expectations.
- Demonstrated accuracy and proficiency in analytical skills.
- Proficiency with Microsoft Office, LIMS, Laboratory Execution Systems, chromatography systems, and electronic laboratory notebook systems.
- Ability to work in a lab environment with appropriate PPE.
- Excellent written and oral communication skills.
- Previous LEAN experience.
- Experience operating/implementing Lab IT systems (e.g., LIMS and automated lab execution systems).
- Cross-functional leadership experience using problem-solving and decision-making.
Benefits
- Company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life insurance/death benefits; time off/leave benefits; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Application Instructions
- Qualified applicants must be authorized to work in the United States full-time; Lilly does not sponsor work authorization/visas.