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Not applicable1 • Fort Lauderdale, Florida, United States
Role & seniority: Quality Engineer – CSV & Digital Systems; mid-senior level (3–5 years relevant experience) in regulated manufacturing/quality, 6-month contract with possible extension, convert-to-perm possible.
Stack/tools: CSV lifecycle (GAMP 5, 21 CFR Part 11/Annex 11, ALCOA+); MES/EBR (e.g., Werum PAS-X), historians (OSIsoft PI), advanced analytics (Seeq), data integrity, change control, CAPA, deviations; data flows, interfaces, and electronic records/signatures.
Review and approve CSV lifecycle documents (VMP, URS, FRS, IQ/OQ/PQ, RTM, summary reports); ensure risk-based validation and data integrity.
Evaluate system changes for GxP impact; support periodic re-validation; assist in inspections and audits.
Act as Quality reviewer/approver for digital systems (MES/EBR, historians, Seeq, Empower/lab systems); ensure data acquisition, time stamping, audit trails, access control, and GxP vs non-GxP separation; collaborate with cross-functional teams.
Must-have skills: Master’s degree in Engineering/CS/Life Sciences; 3–5 years in pharmaceutical/regualted manufacturing with at least 2 years in quality; 3+ years hands-on CSV documentation review/approval; direct experience with manufacturing or utilities systems; strong knowledge of CSV lifecycle, GAMP 5, 21 CFR Part 11/Annex 11, ALCOA+; practical experience with MES/EBR, process historians, and Seeq.
Nice-to-haves: Experience with Werum PAS-X, PI Vision, Power BI; Seeq; Agile
Title: Quality Engineer – CSV & Digital Systems
Contract: 06 Months + (Highest Possibilities of Contract Extension)
Location: Davie, FL 33314 Details
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
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).
Basic Bkg
11 Panel drug + Fentanyl
Medical Screenings:
a. Vision Screen - Near, Far, Color, Depth and Peripheral
b. Spirometry & OSHA Respirator Questionnaire
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
o MES / EBR platforms (e.g., Werum PAS-X or similar)
o Historians (OSIsoft PI or equivalent)
o Advanced analytics tools (Seeq, used for GxP trending)
o 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
o Enable faster project execution with compliant validation strategies
o Avoid over-validation while maintaining inspection readiness
Provide Quality input during project design, FAT/SAT, and commissioning phases.
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).
Required Technical Skills
o MES / EBR systems
o Process Historians (PI, etc.)
o 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 / Nice-to-Have
o FDA inspections related to computerized systems
o Site digitalization or Industry 4.0 initiatives
Key Competencies
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