Consultant

Job Title: Quality Engineer - CSV & Digital Systems Job Duration: 6 months Location: Davie, FL Pay Range: $34-$36.61/hour Job Description: 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 o Avoid over-validation while maintaining inspection readiness • Provide Quality input during project design, FAT/SAT, and commissioning phases. 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: o CSV lifecycle & GAMP 5 o 21 CFR Part 11 / Annex 11 o Data Integrity (ALCOA+) • Practical experience with: 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 • Experience with: o Werum PAS-X, Seeq, PI Vision, Power BI (for regulated trending) o Agile or lean validation approaches o Commissioning & Qualification (C&Q) integration with CSV • Prior involvement in: 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 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).