Engineer - Quality - Global CSQA jobs in United States
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Eli Lilly and Company · 1 day ago

Engineer - Quality - Global CSQA

Eli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Engineer - Quality - Global Computer Systems Quality Assurance role is responsible for ensuring compliance with corporate computer system validation standards and maintaining inspection readiness while supporting various functional areas within the organization.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Ensure supported systems are validated in compliance with applicable standards and procedures
Ensure all quality actions and commitments for supported areas are appropriately tracked
Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
Ensure all Inspection Readiness materials are current and appropriate
Provide periodic updates to key stakeholders
Escalate issues appropriately
Provide consultation and interpretation on policies and procedures as related to the supported computer system
Provide training to customer areas on CSV-related topics as needed
Partner with Business, Business Quality, and IT customer areas to deliver business value
Understand customer, company, and Quality priorities
Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
Engage customers and Quality Assurance management in appropriate discussions of risk management
Ensure suppliers of computer systems or services meet quality expectations
Escalate computer system quality issues to the appropriate persons
Strive for and promote consistency within the CSQA organization
Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality. This may include engagement in process improvement projects
Identify opportunities for streamlining and simplification and assist in developing improved solutions
Understand external trends and potential ramifications for the supported IT area(s)
Share lessons learned and best practices with others
Support teammates by sharing experience, providing backup coverage, consulting and assistance

Qualification

Computer System ValidationIT Systems Development Life CycleRisk AssessmentsSix SigmaQuality AssuranceData AnalyticsIT Best PracticesProcess ImprovementMicrosoft OfficeInformation SecurityProgrammingCloudIT-control CertificationsCommunication SkillsMentoring Skills

Required

Bachelor's degree in a technology-related field such as Computer Science
5+ years' experience in IT, Automation, or computer system validation

Preferred

Understanding of process development and/or improvement (e.g. Six Sigma)
Experience conducting risk assessments, self-inspections, audits and/or supplier assessments
Demonstrated ability to communicate with customers, including good oral and written communication skills and presentation skills
Demonstrated influence, mentoring skills with peers and management
Proficiency with IT systems development life cycle
Proficiency with Microsoft Office products
Experience with Computer Systems Validation
Prior IT system development experience or QA experience
Competency in IT technical disciplines (e.g. Information Security, Programming, Data Analytics, Cloud)
Knowledge of IT Best Practices (e.g., COBIT, LSEF, ITIL, GAMP)
IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))

Benefits

Company bonus
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)

Company

Eli Lilly and Company

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We're a medicine company turning science into healing to make life better for people around the world.

H1B Sponsorship

Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)

Funding

Current Stage
Public Company
Total Funding
$6.5M
2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO

Leadership Team

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David Ricks
Chair, CEO
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Lucas Montarce
Executive Vice President and Chief Financial Officer
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Company data provided by crunchbase