Clark Davis Associates · 1 week ago
CSV Validation Engineer
Coconut Creek, FL
Contract
Onsite
Mid Level
$75/hr - $80/hr
3+ years expClark Davis Associates is seeking a GxP / Computer System Validation (CSV) Engineer responsible for ensuring compliance of computerized systems in regulated environments. The role involves leading validation activities, supporting system lifecycle, and ensuring data integrity compliance.
Professional ServicesRecruitingStaffing Agency
No H1B
U.S. Citizen Only
Responsibilities
Plan, execute, and document CSV activities in accordance with GxP regulations, FDA guidance, EMA guidelines, and industry standards (e.g., GAMP 5)
Develop and review validation deliverables including:
Validation Plans (VP)
User Requirements Specifications (URS)
Functional / Design Specifications (FS/DS)
Risk Assessments
IQ/OQ/PQ protocols and reports
Traceability Matrices
Ensure computerized systems remain in a validated state through effective change control, deviation management, and periodic review
Support validation activities across the full system lifecycle (concept, implementation, operation, and retirement)
Assess the impact of system changes, upgrades, patches, and configuration changes on validation status
Perform vendor assessments and support supplier audits as required
Ensure compliance with data integrity principles (ALCOA+)
Participate in internal audits, regulatory inspections, and customer audits
Respond to audit findings and support CAPA development and execution
Collaborate with IT, Quality Assurance, Engineering, Manufacturing, Clinical, and external vendors
Provide CSV guidance and training to stakeholders
Act as a subject matter expert for CSV and GxP computerized systems
Qualification
Required
Must be a US Citizen or Permanent Resident
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field
3+ years of experience in GxP Computer System Validation in a regulated environment
Strong knowledge of FDA 21 CFR Part 11
Strong knowledge of EU Annex 11
Strong knowledge of GAMP 5
Strong knowledge of Data Integrity principles
Experience validating systems such as ERP (e.g., SAP)
Experience validating systems such as LIMS, MES, QMS
Experience validating systems such as Clinical Trial Management Systems (CTMS)
Experience validating systems such as Laboratory or manufacturing equipment with software components
Excellent documentation, analytical, and communication skills
Preferred
Experience with cloud-based and SaaS systems validation
Familiarity with Agile or SDLC methodologies in regulated environments
Experience supporting FDA, EMA, or other regulatory inspections
CSV certification or quality-related certifications (e.g., ASQ, ISPE)
Company
Clark Davis Associates
Clark Davis Associates offers staffing, recruiting and other professional services.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase