Eli Lilly and Company · 6 hours ago
Associate Director-Test-Methods/Systems-IDM
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$123K/yr - $180K/yr
8+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving the lives of people around the world. The Associate Director - Test Methods/Systems - IDM will be responsible for the strategic development, implementation, and oversight of test methods and systems within the Information and Digitalization Manufacturing organization, ensuring robust testing strategies that support product quality and patient safety.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Lead the design, development, and validation of innovative test methods and strategies for IDM systems, including MES, SCADA, LIMS, and other manufacturing IT/OT platforms
Drive the selection, implementation, and continuous improvement of testing tools, automation frameworks, and test data management solutions
Collaborate with cross-functional teams, including IT, Manufacturing, Quality, and Regulatory Affairs, to define testing requirements and ensure alignment with business objectives and regulatory expectations (e.g., GxP, CFR Part 11)
Develop and maintain comprehensive test plans, protocols, and reports for various system lifecycle phases, from development through deployment and ongoing maintenance
Oversee the execution of testing activities, including functional, integration, performance, and validation testing, ensuring adherence to established procedures and quality standards
Mentor and provide technical guidance to a team of test engineers and specialists, fostering a culture of excellence and continuous learning
Lead efforts to identify and mitigate risks associated with test methods and systems, implementing proactive measures to prevent quality issues
Stay abreast of industry best practices, emerging technologies, and regulatory changes related to software testing, manufacturing IT, and data integrity
Contribute to the development and refinement of IDM testing policies, standards, and procedures
Manage vendor relationships for testing tools and services, ensuring effective collaboration and delivery
Qualification
Required
Bachelor's degree in Computer Science, Information Systems, Engineering, or a related technical field
Minimum of 8-10 years of experience in software testing, quality assurance, or validation roles within a regulated industry (e.g., Pharmaceuticals, Biotechnology, Medical Devices)
At least 3-5 years of experience in a leadership or management role, overseeing testing teams or significant testing initiatives
Deep understanding and hands-on experience with manufacturing IT/OT systems such as MES (e.g., Rockwell PharmaSuite, Werum PAS-X), SCADA, DCS, LIMS, or similar systems
Proven expertise in developing and implementing robust test methodologies, including test automation strategies and frameworks
Strong knowledge of GxP regulations, 21 CFR Part 11, Data Integrity principles, and other relevant industry standards for computerized systems validation
Experience with various testing tools and technologies (e.g., Azure DevOps, HP ALM, Selenium, UFT, JIRA, SQL)
Excellent analytical, problem-solving, and decision-making skills
Exceptional communication (written and verbal) and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders
Ability to manage multiple projects simultaneously and adapt to changing priorities in a fast-paced environment
Preferred
Master's degree in Computer Science, Information Systems, Engineering, or a related technical field
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
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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