Nesco Resource · 9 hours ago
Quality Engineer - (Computer System Validation)
Davie, FL
Full-time
Onsite
Mid Level
$0/hr - $36.61/hr
3+ years expNesco Resource is a staffing company seeking a Quality Engineer specialized in Computer System Validation (CSV) and Digital Systems. The role involves reviewing and approving validation documentation, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to support quality initiatives.
ConsultingHuman ResourcesStaffing Agency
Responsibilities
Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports)
Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, and Data Integrity (ALCOA+) principles
Evaluate system changes through change control, assessing GxP impact and validation requirements
Support periodic reviews and re-validation activities for existing systems
Act as Quality reviewer/approver for systems including:
MES / EBR platforms (e.g., Werum Client-X or similar)
Historians (OSIsoft PI or equivalent)
Advanced analytics tools (Seeq, used for GxP trending)
Empower and other lab systems
Review configurations related to data acquisition, time stamping, audit trails, access control, and electronic records/signatures
Ensure proper segregation between GxP vs non-GxP analytics use cases
Assess and approve data flows, interfaces, and integrations between systems
Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems
Partner with Engineering, Automation, MS&T, IT, and Operations to:
Enable faster project execution with compliant validation strategies
Avoid over-validation while maintaining inspection readiness
Provide Quality input during project design, FAT/SAT, and commissioning phases
Qualification
Required
Recent Master's graduate Master's degree in Engineering, Computer Science, Life Sciences, or related field
Min 3 years experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization
Min 3 years hands-on CSV experience reviewing and approving validation documentation
Direct experience supporting manufacturing or utilities systems (not just lab systems)
Strong working knowledge of: CSV lifecycle & GAMP 5, 21 CFR Part 11 / Annex 11, Data Integrity (ALCOA+)
Practical experience with: MES / EBR systems, Process Historians (PI, etc.), Advanced analytics platforms (Seeq) in a GxP context
Ability to evaluate risk-based validation for dashboards, reports, and models
Familiarity with change control, deviations, and CAPA systems
Preferred
Experience with: Werum Client-X, Seeq, PI Vision, Power BI (for regulated trending)
Agile or lean validation approaches
Commissioning & Qualification (C&Q) integration with CSV
Prior involvement in: FDA inspections related to computerized systems
Site digitalization or Industry 4.0 initiatives
Benefits
MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Company
Nesco Resource
Nesco Resource s an Staffing and Recruiting firm.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Michael McDonald
Executive Vice President of Finance and Chief Accounting Officer
Recent News
InvestmentNews
2023-12-24
Maysville Online
2023-12-24
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