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CSV Engineer/Analyst
Job in
Concord, Merrimack County, New Hampshire, 03306, USA
Listed on 2026-08-12
Listing for:
Pharmatek Consulting Inc.
Full Time
position Listed on 2026-08-12
Job specializations:
-
Quality Assurance - QA/QC
IT QA Tester / Automation
Job Description & How to Apply Below
Concord, United States | Posted on 07/30/2024
- Industry Pharma/Biotech/Clinical Research
- Job Type Full time
- Work Experience 5+ years
- City Concord
- State/Province North Carolina
- Country United States
General lab instrumentvalidation requirements. worked in a lab or have done lab validationbefore for at least a year or 2
CSV expert for that one.
Needsto be a strong personality.
Needs to be onsite 4 days a week.
Needsto be able to create all different validation documents as well as know data integrity
10 plus years experience
RequirementsResponsible for supporting the validation activities for local and global systems.
- Experience in developing and maintaining validation documentation including validation plans, test protocols, test scripts, and summary reports to align with company SOP and regulatory standards.
- Coordinate with technicalevaluation with site Tech@Lilly subject matter experts (SMEs) of new and existing systems from a DI and CSV perspective.
- Responsible for coordinating withcross-functional teams to ensure the alignment of the validation activities.
- Perform data integrity gapassessment and develop remediation plan for computerized systems.
- Responsible for creatingCAPA’s/Deviations and Change Requests in Service Now and Trackwise
- Experience using HPALM forauthoring and executing the Test scripts.
- Experience in performing/supporting computer validations associated with SDLC deliverables
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