CSV Engineer
Job in
Los Angeles, Los Angeles County, California, 90079, USA
Listed on 2026-01-03
Listing for:
TechDigital Group
Full Time
position Listed on 2026-01-03
Job specializations:
-
Engineering
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Keywords – CSV, Computer System Validation, End to end validation, CSA, Computer System Assurance
Roles and Responsibilities- Works on PST time zone
- Background and experience in AGILE SAFE methodology
- Experience in the Pharmaceutical, biotechnology, or medical device industry
- 2+ years' experience with System Development Lifecyle
- 7+ years' experience in Computer System Validation (Based on the role selected)
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
- Knowledge of FDA guidance's and industry standards (i.e., GAMP)
- Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports)
- Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
- Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
- Strong verbal and written communication skills.
- Ability to work as a team player, lead a team or accomplish tasks without supervision.
- Ability to work with remote teams and support several changes/projects simultaneously.
- Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
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