Stefanini North America and APAC · 5 hours ago
Quality Engineer
Fort Lauderdale, FL
Full-time
Onsite
Mid Level
3+ years expStefanini Group is a global provider of outsourcing and IT digital consulting services, and they are seeking a Quality Engineer. The role involves ensuring compliance through Computer System Validation (CSV) processes and collaborating with cross-functional teams to maintain quality standards in regulated manufacturing environments.
Information TechnologyOutsourcing
Responsibilities
Computer System Validation (CSV)
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 PAS-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
Master's degree in Engineering, Computer Science, Life Sciences, or related field
3-5 years' experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization
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
Risk-based decision making with quality and compliance focus
Strong documentation review and technical writing skills
Ability to challenge constructively while remaining solution-oriented
Comfortable working at the intersection of Quality, Engineering, and IT
Pragmatic mindset: compliant and business-enabling
Preferred
Experience with: Werum PAS-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
Company
Stefanini North America and APAC
Global Tech Consulting Company All in One. Stefanini is a Brazilian multinational company with 37 years of experience and presence in 41 countries.
10001+ employees
H1B Sponsorship
Stefanini North America and APAC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (11)
2023 (13)
2022 (18)
2021 (14)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
Spencer Gracias
CEO, North America/APAC
David Gawenda
Chief Operating Officer NA/APAC Region
Recent News
GlobalFinTechSeries
2026-02-07
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2025-12-30
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2025-12-13
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