Your Responsibilities:
- 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 5–7 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
Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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