Shoolin Inc

Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…

EngineeringLife SciencesPharmaceuticalRecruitmentScienceStaffingTalent AcquisitionTechnology Solutionsshoolin-inc.com

Shoolin Inc

Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…

EngineeringLife SciencesPharmaceuticalRecruitmentScienceStaffingTalent AcquisitionTechnology Solutionsshoolin-inc.com

HQIselin, US

Team Size60

Open Jobs21

Total Funding-

Latest FundraiseUnknown

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Computer System Validation (CSV) Engineer

On-SiteCalifornia, US

On-Site • California, US

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Job Title: Computer System Validation (CSV) Engineer

Location: Irvine, CA (Onsite)

Duration: Long Term

Overview:

Seeking a Computer System Validation (CSV) Engineer with 2–3 years of experience to support validation of GxP-regulated systems in a pharmaceutical/biotech environment. The role involves ensuring compliance, executing validation activities, and supporting system lifecycle management.

Required Experience:

2–3 years of experience in Computer System Validation (CSV)
Experience in GxP/FDA-regulated environments
Hands-on experience with validation lifecycle (IQ, OQ, PQ)
Knowledge of 21 CFR Part 11 and data integrity requirements
Experience with validation documentation and testing (URS, FS, DS, RTM)

Key Responsibilities:

Execute CSV activities including planning, testing, and documentation
Develop and review validation deliverables (protocols, reports, traceability matrix)
Ensure systems comply with regulatory and data integrity requirements
Support audits and address validation-related observations
Collaborate with QA, IT, and business teams for system implementation and validation