Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards
Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports
Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis
Partner cross-functionally with IT, Engineering, Automation, and Operations to implement and maintain compliant computerized systems
Support continuous improvement of site Quality Systems through SOP development, training, coaching, and change control management
What You Need to Succeed (minimum qualifications):
Education: Bachelor's Degree in Science, Technology, Engineering, Computer Science, or a related technical discipline (or equivalent experience)
Required Experience: Minimum 10 years of experience in a GxP regulated environment (Pharmaceutical, Biotech, or Medical Device), including at least 3-5 years of experience in Computer System Validation (CSV) or Computer System Quality Assurance (CSQA)
Top 2 Skills: Strong knowledge of Data Integrity and computerized system validation regulations (21 CFR Part 11, Annex 11, ALCOA++), and ability to influence and coach cross-functional technical teams on compliance requirements
What will give you a competitive edge (preferred qualifications):
Professional certifications such as CISA (Certified Information Systems Auditor) or CSQE (Certified Software Quality Engineer)
Experience supporting Data Integrity audits and regulatory inspections
Experience with regulated system platforms such as SAP, Veeva, MES, or LIMS
Experience implementing risk-based validation approaches aligned with GAMP 5
Experience supporting manufacturing or laboratory systems in regulated environments
Additional Information:
Location: Clinton, IN - Onsite Manufacturing Facility
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Benefits
Health insuranceVision insurance401(k)Paid time offFlexible schedulePerformance bonusParental leave
Additional Information
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Quality Assurance - Computer System Validation (CSV)
As the Quality Assurance - Computer System Validation (CSV) , you will be part of the Quality organization supporting Clinton Manufacturing Operations. In this role, you will provide quality oversight for computerized systems used in GxP operations, ensuring compliance with global regulatory requirements and data integrity standards. You will partner with IT, Automation, Engineering, and Production teams to maintain validated systems and integrate compliant digital solutions across the site.
Elanco · Clinton, IN