Quality Engineer - CSV & Digital Systems

Quality Engineer – CSV & Digital Systems Location: Davie, FL Job Duration: 6 months Contract Shift: Monday to Friday 8am – 5 pm (40 hours per week) Assignment Duration: 6 months with possible extension Convert to Perm: Depending on openings 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). 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 GAMP5,21 CFRPart 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: 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. 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: 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. 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). Required Technical Skills: Strong working knowledge of: CSV lifecycle & GAMP 5 21 CFR Part 11 / Annex 11 Data Integrity (ALCOA+) Practical experience with: MES / EBR systems 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: 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 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 #J-18808-Ljbffr