Full Description

Title: Quality Engineer – CSV & Digital Systems Davie, FL

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.
• 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).

Medical screening requirements

Screenings

• Basic Bkg
• 11 Panel drug + Fentanyl

Medical Screenings

a. Vision Screen - Near, Far, Color, Depth and Peripheral

b. Spirometry & OSHA Respirator Questionnaire

Key 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.

Digital Systems & Platforms

Act as Quality reviewer/approver for systems including

• 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.

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

• o Enable faster project execution with compliant validation strategies