Computer Validation Specialist I
Labcorp
The Validation Engineer (Computer Validation Specialist) plays a critical role in supporting data integrity assessments and ongoing compliance initiatives aligned with regulatory requirements. This position ensures the continued validation and regulatory continuity of computerized systems at sites in Indianapolis and Greenfield, while also delivering key support during sponsor and regulatory audits.
This role is one of only six global resources supporting regulatory compliance for a large portfolio of validated systems. The Validation Engineer will have significant impact on maintaining quality, mitigating compliance risks, and ensuring successful regulatory inspections.
**Key Responsibilities:**
+ Support ongoing Computer System Compliance through direct site involvement, authoring, reviewing, and guiding documentation for both internal business and external client-driven system changes.
+ Execute compliance and validation documentation in alignment with regulatory guidelines and internal SLC (System Lifecycle) policies.
+ Provide IT regulated audit support during both sponsor and regulatory authority audits.
+ Ensure timely delivery of tasks based on U.S. Eastern Time Zone requirements, often requiring same-day turnaround.
+ Contribute to broader validation workstreams, including SLC enhancement initiatives, metrics gathering, and reporting.
+ Deliver on-site support for validation projects, ensuring alignment with business priorities and regulatory expectations.
**Requirements:**
+ Experience in computer system validation, data integrity, or quality assurance within a regulated industry (e.g., pharma, biotech, CRO).
+ Strong knowledge of GxP regulations, CSV best practices, and audit readiness.
+ Ability to work independently under tight deadlines and across multiple projects.
+ Excellent communication and documentation skills.
+ Must be able to work U.S. Eastern Time hours with responsiveness to short turnaround times.
+ High School Diploma required
**Application Window closes 5/23/2025**
**Pay Range:** $45,000 - $70,000 annual salary
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
**Benefits** : Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
**Labcorp is proud to be an Equal Opportunity Employer:**
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
**We encourage all to apply**
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