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Quality Engineer – CSV & Digital Systems
Job in
Fort Lauderdale, Broward County, Florida, 33336, USA
Listed on 2026-03-01
Listing for:
Not applicable1
Full Time
position Listed on 2026-03-01
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Overview
Title: Quality Engineer – CSV & Digital Systems
Contract: 06 Months + (Highest Possibilities of Contract Extension)
Location: Davie, FL 33314
Description: Title:
Quality Engineer – CSV & Digital Systems
Shift Details: Monday to Friday 8am – 5 pm (40 hours per week)
Assignment Duration: 6 months with possible extension
Convert to Perm: Depending on opens and performance
Core Essential skill sets (must have):
- Recent Master’s graduate Master's degree in Engineering, Computer Science, Life Sciences, or related field.
- Min3 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).
Medical screening requirements:
Screenings:
Medical Screenings:
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.
Digital Systems & Platforms
- Act as Quality reviewer/approver for systems including:
- oMES / E platforms (e.g., Werum PAS-X or similar)
- oHistorians (OSIsoft PI or equivalent)
- oAdvanced analytics tools (Seeq, used for GxP trending)
- oEmpower 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.
Data Integrity & Compliance:
- 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:
- oEnable faster project execution with compliant validation strategies
- oAvoid over-validation while maintaining inspection readiness
- Provide Quality input during project design, FAT/SAT, and commissioning phases.
Required Qualifications:
Education:
- Master's degree in Engineering, Computer Science, Life Sciences, or related field.
Experience:
- 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).
Position Requirements
5+ Years
work experience
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