ICONMA · 1 day ago
Quality Engineer – CSV & Digital Systems
Davie, FL
Full-time
Onsite
Mid Level
$0/hr - $36.61/hr
3+ years expICONMA is a pharmaceutical company looking for a Quality Engineer – CSV & Digital Systems for their Davie, FL location. The role involves reviewing and approving CSV lifecycle documents, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to maintain quality in digital systems.
Staffing & Recruiting
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 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
Cross-Functional Collaboration
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)
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
Werum PAS-X, Seeq, PI Vision, Power BI (for regulated trending)
Agile or lean validation approaches
Commissioning & Qualification (C&Q) integration with CSV
FDA inspections related to computerized systems
Site digitalization or Industry 4.0 initiatives
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
Benefits
Health Benefits
Referral Program
Company
ICONMA
ICONMA: Your Partner in Global Staffing Solutions and Digital Transformation ICONMA is a globally recognized, Woman-Owned staff augmentation and technology consulting firm.
1001-5000 employees
H1B Sponsorship
ICONMA 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 (34)
2024 (31)
2023 (26)
2022 (39)
2021 (37)
2020 (69)
Funding
Current Stage
Late StageLeadership Team
Claudine George
Founder and CEO of ICONMA, LLC
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