ACR Group · 2 days ago
Computer System Validation (CSV ) Engineer (Only United Citizen & Green Card)
United States
Full-time
Remote
Senior Level
$60/hr - $70/hr
7+ years expACR Technology Inc is seeking a CSV Engineer to lead and execute Computer System Validation activities for GMP computerized systems. The role involves ensuring compliance and validation throughout the system lifecycle while collaborating with various teams to support system configuration and data integrity initiatives.
Automotive
No H1B
U.S. Citizen Only
Responsibilities
Lead CSV lifecycle activities including implementation, production support, change management, and periodic reviews
Author, review, approve, and execute validation deliverables including validation plans, risk assessments, IQ/OQ/PQ protocols, test scripts, and final reports
Support validation of laboratory and manufacturing computerized systems including: Chromeleon, LabWare, Database, LIMS, Network Qualification, QMS, Laboratory standalone instruments, DeltaV and other manufacturing control systems
Provide administration and technical support for laboratory systems, CDS platforms, and instrument integrations
Define validation strategies for system upgrades, patches, and enhancements with strong focus on data integrity and regulatory compliance
Support change control, deviation resolution, and maintenance of validated state
Assist in configuration and customization of systems according to business and compliance requirements
Support on boarding and integration of new laboratory instruments and computerized systems
Conduct end-user training and provide ongoing operational support
Ensure adherence to cGMP, electronic records/signature requirements, and company Code of Conduct
Qualification
Required
Bachelor's degree in Computer Science, Engineering, or related field (or equivalent experience)
7+ years of experience in Computer System Validation within pharmaceutical or biotech environments
Strong knowledge of cGMP requirements
Strong knowledge of Paper less Validation Tools
Strong knowledge of 21 CFR Part 11
Strong knowledge of Data Integrity principles
Strong knowledge of CSV lifecycle management
Hands-on experience with laboratory systems and/or manufacturing automation platforms
Company
ACR Group
ACR Group is a distributor of automotive parts, tools, and replacement kits.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase